6\. Study Site Information

+-----------------------------------------------------------------------+
| **SITES:**                                                            |
|                                                                       |
| **1.**                                                                |
+-----------------------------------------------------------------------+
| Wilford Hall Medical Center                                           |
+-----------------------------------------------------------------------+
| Lackland AFB, TX                                                      |
+-----------------------------------------------------------------------+
| 78236-5300                                                            |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| Stephen Derdak DO                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **2.**                                                                |
|                                                                       |
| The Toronto Hospital                                                  |
+-----------------------------------------------------------------------+
| 200 Elizabeth Street                                                  |
+-----------------------------------------------------------------------+
| Toronto, Ontario                                                      |
+-----------------------------------------------------------------------+
| M5G2C4/Canada                                                         |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| John Granton, MD                                                      |
+-----------------------------------------------------------------------+

+---+-----------------------------------------------------------------+---+
|   | **3a.**                                                         |   |
|   |                                                                 |   |
|   | The Wellesley Hospital                                          |   |
+---+-----------------------------------------------------------------+---+
|   | 160 Wellesley St. East                                          |   |
+---+-----------------------------------------------------------------+---+
|   | Toronto, Ontario                                                |   |
+---+-----------------------------------------------------------------+---+
|   | M4Y1J3, Canada                                                  |   |
+---+-----------------------------------------------------------------+---+
|   | **PI**                                                          |   |
|   |                                                                 |   |
|   | Thomas Stewart MD                                               |   |
+---+-----------------------------------------------------------------+---+
| * |                                                                 |   |
| * |                                                                 |   |
| 3 |                                                                 |   |
| b |                                                                 |   |
| . |                                                                 |   |
| * |                                                                 |   |
| * |                                                                 |   |
|   |                                                                 |   |
| M |                                                                 |   |
| o |                                                                 |   |
| u |                                                                 |   |
| n |                                                                 |   |
| t |                                                                 |   |
| S |                                                                 |   |
| i |                                                                 |   |
| n |                                                                 |   |
| a |                                                                 |   |
| i |                                                                 |   |
| H |                                                                 |   |
| o |                                                                 |   |
| s |                                                                 |   |
| p |                                                                 |   |
| i |                                                                 |   |
| t |                                                                 |   |
| a |                                                                 |   |
| l |                                                                 |   |
+---+-----------------------------------------------------------------+---+
| 6 |                                                                 |   |
| 0 |                                                                 |   |
| 0 |                                                                 |   |
| U |                                                                 |   |
| n |                                                                 |   |
| i |                                                                 |   |
| v |                                                                 |   |
| e |                                                                 |   |
| r |                                                                 |   |
| s |                                                                 |   |
| i |                                                                 |   |
| t |                                                                 |   |
| y |                                                                 |   |
| A |                                                                 |   |
| v |                                                                 |   |
| e |                                                                 |   |
| n |                                                                 |   |
| u |                                                                 |   |
| e |                                                                 |   |
+---+-----------------------------------------------------------------+---+
| T |                                                                 |   |
| o |                                                                 |   |
| r |                                                                 |   |
| o |                                                                 |   |
| n |                                                                 |   |
| t |                                                                 |   |
| o |                                                                 |   |
| , |                                                                 |   |
| O |                                                                 |   |
| n |                                                                 |   |
| t |                                                                 |   |
| a |                                                                 |   |
| r |                                                                 |   |
| i |                                                                 |   |
| o |                                                                 |   |
+---+-----------------------------------------------------------------+---+
| M |                                                                 |   |
| 5 |                                                                 |   |
| G |                                                                 |   |
| 1 |                                                                 |   |
| X |                                                                 |   |
| 6 |                                                                 |   |
| / |                                                                 |   |
| C |                                                                 |   |
| a |                                                                 |   |
| n |                                                                 |   |
| a |                                                                 |   |
| d |                                                                 |   |
| a |                                                                 |   |
+---+-----------------------------------------------------------------+---+
| * |                                                                 |   |
| * |                                                                 |   |
| P |                                                                 |   |
| I |                                                                 |   |
| * |                                                                 |   |
| * |                                                                 |   |
|   |                                                                 |   |
| T |                                                                 |   |
| h |                                                                 |   |
| o |                                                                 |   |
| m |                                                                 |   |
| a |                                                                 |   |
| s |                                                                 |   |
| S |                                                                 |   |
| t |                                                                 |   |
| e |                                                                 |   |
| w |                                                                 |   |
| a |                                                                 |   |
| r |                                                                 |   |
| t |                                                                 |   |
| , |                                                                 |   |
| M |                                                                 |   |
| D |                                                                 |   |
+---+-----------------------------------------------------------------+---+

+-----------------------------------------------------------------------+
| **4.**                                                                |
|                                                                       |
| Maine Medical Center                                                  |
+-----------------------------------------------------------------------+
| 22 Bramhall Drive                                                     |
+-----------------------------------------------------------------------+
| Portland, ME                                                          |
+-----------------------------------------------------------------------+
| O4102                                                                 |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| Sandy Bagwell, MD                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **5.**                                                                |
|                                                                       |
| Bronson Medical Center                                                |
+-----------------------------------------------------------------------+
| 252 E. Lovell Street                                                  |
+-----------------------------------------------------------------------+
| Kalamazoo, MI                                                         |
+-----------------------------------------------------------------------+
| 49007-5345                                                            |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| Bill Shillingwall DO                                                  |
+-----------------------------------------------------------------------+

**IRB's:**

+-----------------------------------------------------------------------+
| Darlene Castro                                                        |
|                                                                       |
| Clinical Research Div.                                                |
+-----------------------------------------------------------------------+
| AF Medical Operations                                                 |
+-----------------------------------------------------------------------+
| Office Surgeon General                                                |
+-----------------------------------------------------------------------+
| Bolling AFB,DC 20332                                                  |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| M Elvis                                                               |
+-----------------------------------------------------------------------+
| Medical Research Directorate                                          |
+-----------------------------------------------------------------------+
| CCRW 2-814                                                            |
+-----------------------------------------------------------------------+
| The Toronto Hospital                                                  |
+-----------------------------------------------------------------------+
| 200 Elizabeth Street                                                  |
|                                                                       |
| Toronto, Ontario                                                      |
|                                                                       |
| M5G2C4, Canada                                                        |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| E Keystone                                                            |
+-----------------------------------------------------------------------+
| Research Institute                                                    |
+-----------------------------------------------------------------------+
| The Wellesley Hospital                                                |
+-----------------------------------------------------------------------+
| 160 Wellesley St. East                                                |
+-----------------------------------------------------------------------+
| Toronto, Ontario                                                      |
|                                                                       |
| M4Y1J3, Canada                                                        |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| Bill Wilson                                                           |
+-----------------------------------------------------------------------+
| Mount Sinai Hospital                                                  |
+-----------------------------------------------------------------------+
| 600 University Avenue                                                 |
|                                                                       |
| Toronto, Ontario                                                      |
+-----------------------------------------------------------------------+
| M5G1X6/Canada                                                         |
+-----------------------------------------------------------------------+

  -----------------------------------------------------------------------
  D Hayes MD

  MMC-Research Institute

  125 John Roberts Road

  Suite 5

  S. Portland, ME 04106
  -----------------------------------------------------------------------

  -----------------------------------------------------------------------
  Robert Hume MD

  Bronson Medical Center

  252 E. Lovell Street

  Kalamazoo, MI

  49007-5345
  -----------------------------------------------------------------------

**Key Dates/Info:**

+-----------------------------------------------------------------------+
| IRB Approval: 8/5/97                                                  |
|                                                                       |
| First subject: 10/26/97                                               |
|                                                                       |
| Patients enrolled: 20                                                 |
+-----------------------------------------------------------------------+

IRB approval: 7/7/97

First subject: 12/11/97

Patients enrolled: 21

IRB approval: 8/28/97

First subject: 12/4/97

Patients enrolled: 5

ICU closed and study terminated: 6/1/98

+-----------------------------------------------------------------------+
| IRB approval: 10/13/98                                                |
|                                                                       |
| First subject: 8/25/98                                                |
|                                                                       |
| Patients enrolled: 14                                                 |
+-----------------------------------------------------------------------+

IRB approval: 6/25/97

First subject: 1/28/98

Patients enrolled: 15

IRB approval: 8/14/97

First subject: 3/14/98

Patients enrolled: 1

Study terminated: 10/30/98

**SITES:**

+-----------------------------------------------------------------------+
| **6.**                                                                |
|                                                                       |
| Loma Linda University MC                                              |
+-----------------------------------------------------------------------+
| 11234 Anderson Street                                                 |
|                                                                       |
| Loma Linda CA,                                                        |
+-----------------------------------------------------------------------+
| 92354                                                                 |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| Ronald Perkins MD                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **7.**                                                                |
|                                                                       |
| University Virginia Hospital                                          |
+-----------------------------------------------------------------------+
| P.O. Box 10010                                                        |
+-----------------------------------------------------------------------+
| Charlottesville, VA                                                   |
+-----------------------------------------------------------------------+
| 22906                                                                 |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| Stuart Lowson MB.B                                                    |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **8.**                                                                |
|                                                                       |
| Allegheny General Hospital                                            |
+-----------------------------------------------------------------------+
| 320 East Avenue                                                       |
+-----------------------------------------------------------------------+
| Pittsburgh, PA                                                        |
+-----------------------------------------------------------------------+
| 15212-4772                                                            |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| Brian Carlin MD                                                       |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **9.**                                                                |
|                                                                       |
| Barnes Jewish-Washington Univ MC                                      |
+-----------------------------------------------------------------------+
| One Barnes Hospital Plaza                                             |
+-----------------------------------------------------------------------+
| St Louis MO                                                           |
+-----------------------------------------------------------------------+
| 63110-1093                                                            |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| Timothy Buchman MD PhD                                                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **10.**                                                               |
|                                                                       |
| SunnyBrooke Health Science                                            |
+-----------------------------------------------------------------------+
| 2075 Bayview Avenue                                                   |
+-----------------------------------------------------------------------+
| North York, Ontario                                                   |
+-----------------------------------------------------------------------+
| Canada M4N3M5                                                         |
+-----------------------------------------------------------------------+
| **PI**                                                                |
|                                                                       |
| Terry Smith MD                                                        |
+-----------------------------------------------------------------------+

IRB's:

+-----------------------------------------------------------------------+
| William Saukel MD.                                                    |
+-----------------------------------------------------------------------+
| LLUMC IRB                                                             |
+-----------------------------------------------------------------------+
| 11188 Anderson Street                                                 |
|                                                                       |
| Loma Linda CA,                                                        |
+-----------------------------------------------------------------------+
| 92354                                                                 |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| David A Peura MD                                                      |
+-----------------------------------------------------------------------+
| Human Investigations Comm.                                            |
+-----------------------------------------------------------------------+
| UVa Health System                                                     |
+-----------------------------------------------------------------------+
| P.O. Box 483                                                          |
+-----------------------------------------------------------------------+
| Charlottesville, VA                                                   |
|                                                                       |
| 22908                                                                 |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| Richard N Fogoros MD.                                                 |
+-----------------------------------------------------------------------+
| IRB Allegheny General Hospital                                        |
+-----------------------------------------------------------------------+
| 320 East Avenue                                                       |
|                                                                       |
| Pittsburgh, PA                                                        |
+-----------------------------------------------------------------------+
| 15212-4772                                                            |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| P Girgsley                                                            |
+-----------------------------------------------------------------------+
| WUMC-IRB                                                              |
+-----------------------------------------------------------------------+
| Washington University                                                 |
+-----------------------------------------------------------------------+
| P.O. Box 8089                                                         |
|                                                                       |
| St Louis, MO                                                          |
+-----------------------------------------------------------------------+
| 63110-1093                                                            |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| Philip Hebert MD PhD                                                  |
+-----------------------------------------------------------------------+
| Research Ethics Board                                                 |
+-----------------------------------------------------------------------+
| SunnyBrooke Health Science                                            |
+-----------------------------------------------------------------------+
| 2075 Bayview Avenue                                                   |
|                                                                       |
| North York, Ontario                                                   |
+-----------------------------------------------------------------------+
| Canada M4N3M5                                                         |
+-----------------------------------------------------------------------+

**Key Dates/Info:**

IRB Approval: 7/8/98

First subject: 10/8/98

Patients enrolled: 11

IRB approval: 10/13/98

First subject: 3/16/99

Patients enrolled: 17

IRB approval: 8/21/98

First subject: 3/30/99

Patients enrolled: 7

IRB approval: 84/7/99

First subject: 5/20/99

Patients enrolled: 27

IRB approval: 1/27/99

First subject: 11/1/99

Patients enrolled: 10

  ------------- ------------- -------- ---------- ---------- -------- -------- -------- --------
  patid         vent          EXIT     status30   status6m   IHTTxF   newPTX   DurHFO   DurMV

  1.01          0             2        0          0          0        0        2.7      9

  1.02          1             2        0          0          0        0                 2

  1.03          1             3        2          0          0        0                 88

  1.04          0             5        3          3          0        1        13       23

  1.05          1             5        3          3          0        0                 0.1

  1.06          1             5        3          3          0        1                 1.1

  1.07          1             3        2          0          0        0                 60

  1.08          0             2        2          0          0                 5        26

  1.09          0             2        0          0          0        0        6        13

  1.1           1             5        3          3          0                          3.3

  1.11          0             2        2          3          0        0        2        27

  1.12          1             5        3          3          0        0                 18

  1.13          1             5        3          3          1                          3.4

  1.14          0             2        2          0          0                 3.5      23

  1.15          0             5        3          3          0                 0        0

  1.16          0             3        2          0          0        0        5        53

  1.17          1             6        2          0          0        0                 22

  1.18          0             5        3          3          0        0        5        5

  1.19          0             5        3          3          0                 0.9      0.9

  1.2           1             5        3          3          0        0                 8

  2.01          1             2        0          0          0        0                 10

  2.02          1             3        2          3          0        0                 39

  2.03          0             3        2          0          0        0        26       39

  2.04          1             2        0          0          0        0                 18

  2.05          0             3        2          0          0                 2.5      57

  2.06          1             2        0          0          0        0                 6

  2.07          0             4        3          3          0        0        4        6

  2.08          0             1        3          3          0        0        0.75     5

  2.09          1             5        3          3          0        0                 6

  2.1           1             3        2          3          0        1                 31

  2.11          0             5        3          3          0        0        3        7

  2.12          1             5        3          3          0        0                 5

  2.13          0             3        2          0          0        0        5        30

  2.14          1             2        0          0          0        0                 19

  2.15          0             2        2          0          0        0        4        29

  2.16          1             6        2          2          0        0                 180

  2.17          0             5        3          3          0        0        4        14

  2.18          0             3        2          0          0        0        1        133

  2.19          0             5        3          3          0        0        1        21

  2.2           1             6        3          3          0        0                 12

  2.21          0             3        2          0          0        0        8        41

  3.01          1             1        3          3          0        0                 4

  3.02          0             3        2          0          0        0        13       50

  3.03          1             5        3          3          0        0                 18

  3.04          0             5        3          3          0        0        5        27

  3.05          1             5        3          3          0        0                 18

  3.06          1             5        3          3          0        0                 3

  3.07          0             3        2          3          0        1        30       36

  3.08          0             2        0          0          0        0        3        7

  3.09          1             3        2          2          0        1                 182

  3.1           0             5        3          3          0        0        3        10

  3.11          1             5        3          3          0        0                 2.5

  3.12          1             5        3          3          0                          1.1

  3.13          1             1        3          3          0        1                 1.5

  3.14          0             5        3          3          0                 4        10

  3.15          1             5        3          3          0        0                 2.75

  3.16          0             2        0          0          0        0        1.7      2.3

  3.17          1             1        2          3          0                          30

  3.18          0             5        3          3          0        0        1.5      1.5

  3.19          0             5        3          3          0        0        11       11

  4.01          0             2        0          0          0        0        9        18

  4.02          0             6        2          3          0        0        0.3      42

  4.03          0             2        0          0          0        0        3        7

  4.04          1             5        3          3          0        0                 23

  4.05          1             5        3          3          0                          12

  4.06          1             2        0          0          0        0                 18

  4.07          0             3        2          0          0        0        11       57

  4.08          1             5        3          3          0        0                 4

  4.09          1             3        2          0          0        0                 43

  4.1           0             5        3          3          0                          6

  4.11          0             6        3          3          0        0        0.5      4

  4.12          1             5        3          3          0        0                 0.1

  4.13          1             3        2          3          0        0                 34

  4.14          0             3        2          0          0        0        2.3      85

  4.15          0             5        3          3          0                 3        13

  5.01          0             4        0          0          0        0        10.4     22

  6.01          0             3        2          3          0        1        14.5     33

  6.02          1             2        0          0          0        0                 10

  6.03          1             5        3          3          0        0                 8

  6.04          0             5        3          3          0        0        16       23

  6.05          0             2        2          0          0        0        4        8

  6.06          1             5        3          3          0                          28

  6.07          0             3        2          3          0        1        7        38

  6.08          1             2        0          0          0        0                 22

  6.09          1             1        3          3          0                          8.9

  6.1           0             2        0          0          0        0        5.2      11.2

  6.11          0             2        2          0          0        0        11.5     25

  7.01          1             3        0          0          0                          14

  7.02          0             4        3          3          0                 7        8

  7.03          0             3        2          0          0                 6        31

  7.04          1             2        0          0          0                          4

  7.05          0             2        0          0          0        0        11       19

  7.06          1             5        3          3          0        0                 0

  7.07          1             2        0          0          0        0                 6

  7.08          0             2        2          0          0        0        12       16

  7.09          0             5        3          3          0        0        6        6

  7.1           1             2        2          0          0        0                 7

  7.11          1             5        3          3          0        0                 0.8

  7.12          1             5        3          3          0        0                 5

  7.13          1             2        0          0          0        0                 10

  7.14          1             5        3          3          0        0                 18

  7.15          0             2        0          0          0        0        8        14

  7.16          0             2        2          0          0        0        10       23

  7.17          1             5        3          3          0        0                 30

  8.01          1             1        2          3          0        0                 44

  8.02          0             2        0          0          0        0        5        12

  8.03          1             2        0          0          0                          13

  8.04          0             2        0          0          0        0        5        10

  8.05          0             2        2          0          0        0        3.7      10

  8.06          1             5        3          3          0                          0.4

  8.07          0             3        2          3          0        0                 38

  9.01          0             2        0          0          0        0        3.5      11.5

  9.02          1             5        3          3          0        0                 1.4

  9.03          1             2        0          0          0        1                 15

  9.04          0             4        2          0          0        0        4.8      30

  9.05          0             2        0          0          0        0        2.5      24

  9.06          1             2        0          0          0        0                 20

  9.07          0             5        3          3          0        0        3        3

  9.08          1             5        3          3          0        0                 19

  9.09          0             1        0          0          0        0        2        10

  9.1           1             5        3          3          0        0                 4.3

  9.11          1             2        0          0          0        0                 5

  9.12          0             2        2          0          0        0        4        32

  9.13          0             5        3          3          0        0        1.5      1.5

  9.14          1             5        3          3          0        0                 4.3

  9.15          1             5        3          3          0                          30

  9.16          0             3        2          0          0                 16       35

  9.17          1             2        2          0          0        0                 62

  9.18          0             5        3          3          0        0        2.3      2.3

  9.19          1             2        0          0          0        0                 17

  9.2           0             2        3          3          0        1        10       23

  9.21          0             5        3          3          0        0        3.3      3.3

  9.22          1             2        0          0          0                          23

  9.23          1             1        0          0          0        0                 24

  9.24          0             2        2          0          0        0        3.4      29

  9.25          1             2        2          0          0        0                 28

  9.26          0             2        0          0          0                 2.7      16

  9.27          0             5        3          3          0                 3.7      5.8

  10.01         0             3        2          0          0        0        4        74

  10.02         0             5        3          3          0        0        3        16

  10.03         1             5        3          3          0        0                 4

  10.04         1             1        3          3          0        0                 9

  10.05         1             5        3          3          1        0                 2

  10.06         0             2        2          3          0        0        1.7      11

  10.07         0             2        2          0          0        0        13       24

  10.08         1             6        2          0          0        0                 22

  10.09         1             1        2          0          0        0                 42

  10.1          0             5        3          3          0        0        4.2      4.2

                                                                                        

                                                                                        

                                                                                        

  Explanation                                                                           
  of Header                                                                             
  Codes                                                                                 

  patid         First digit   center                                                    

  vent          0=HFOV        1=CMV                                                     

  status30      2=                                                                      
                respiratory                                                             
                support, 3=                                                             
                death                                                                   

  status6m      2=                                                                      
                respiratory                                                             
                support, 3=                                                             
                death                                                                   

  IHTTxF        1= treatment                                                            
                failure                                                                 
                intractable                                                             
                hypotension                                                             

  newPTX        1= new air                                                              
                leak                                                                    

  DurHFO        days of HFO                                                             

  DurMV         days of                                                                 
                mechanical                                                              
                ventilation                                                             
                (CV+HFO)                                                                

                                                                                        
  ------------- ------------- -------- ---------- ---------- -------- -------- -------- --------

This is a log of events reported by the sites on the \"Unanticipated
Events\" Case Report Form, as well as events identified while reviewing
the patient data packets. The Adverse Events CRF indicates that only
HFOV FAILURES , PROTOCOL VIOLATIONS and UNANTICIPATED ADVERSE EVENTS
should be reported.

+-------+-----+---+---------------------------------------------------+
| Date  | Pat | V | comment                                           |
|       | \#  | e |                                                   |
|       |     | n |                                                   |
|       |     | t |                                                   |
+-------+-----+---+---------------------------------------------------+
| 10/   | 1   | H | mucus plug during CV, also diarrhea, skin problem |
| 27/97 | .01 | F | noted                                             |
+-------+-----+---+---------------------------------------------------+
| 11    | 1   | C | patient bagged during transport, no exacerbation  |
| /2/97 | .02 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 11    | 1   | C | patient extubated early due to mucus plug         |
| /4/97 | .02 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 12/   | 3   | H | after 8 hrs HFO, patient returned from OR and     |
| 31/97 | .02 | F | left on CV                                        |
+-------+-----+---+---------------------------------------------------+
| 1/    | 3   | C | Only enrollment and outcome data available        |
| 16/98 | .03 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 3/    | 5   | H | Only enrollment & outcome data available          |
| 14/98 | .01 | F |                                                   |
+-------+-----+---+---------------------------------------------------+
| 2/    | 4   | H | Patient withdrawn after 8 hours because no ARDS   |
| 11/98 | .02 | F |                                                   |
+-------+-----+---+---------------------------------------------------+
| 3/    | 2   | H | unable to ventilate, resolved with removal of     |
| 26/98 | .03 | F | ETTube                                            |
|       |     |   |                                                   |
|       |     |   | mucus plug                                        |
+-------+-----+---+---------------------------------------------------+
| 4     | 1   | C | post op MI & block 5 months after study exit      |
| /1/98 | .02 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 4/    | 2   | H | false alarm (pressure sensor failure) day 3,      |
| 18/98 | .05 | F | switched to CV                                    |
+-------+-----+---+---------------------------------------------------+
| 5     | 1   | H | driver overheated day 2, placed on 2nd HFO        |
| /9/98 | .04 | F | without                                           |
|       |     |   |                                                   |
|       |     |   | de-sat                                            |
+-------+-----+---+---------------------------------------------------+
| 5/    | 1   | H | Right main stem mucus plug with desat ,           |
| 11/98 | .04 | F |                                                   |
|       |     |   | resolved with suctioning                          |
+-------+-----+---+---------------------------------------------------+
| 8/    | 1   | C | cardiac arrest unrelated to study at 3hrs         |
| 14/98 | .05 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 8/    | 1   | C | cardiac arrest from tension pneumothorax day 1,   |
| 18/98 | .06 | V |                                                   |
|       |     |   | successful CPR                                    |
+-------+-----+---+---------------------------------------------------+
| 8/    | 2   | H | exit for neurological evaluation day 1            |
| 18/98 | .08 | F |                                                   |
+-------+-----+---+---------------------------------------------------+
| 8/    | 1   | C | heart failure (DNR) day 4                         |
| 19/98 | .06 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 8/    | 1   | H | undetected leak in circuit, uneventful switch to  |
| 19/98 | .07 | F | CMV                                               |
+-------+-----+---+---------------------------------------------------+
| 9/    | 3   | C | entry delayed because of in hospital transport    |
| 21/98 | .09 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 12/   | 4   | C | Assist control cmv during transport               |
| 26/99 | .05 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 1     | 4   | C | Assit control mode after TxF-RespAcid day 7       |
| /5/99 | .05 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 1/    | 1   | H | desat during ETT change .                         |
| 25/99 | .09 | F |                                                   |
+-------+-----+---+---------------------------------------------------+
| 2/    | 1   | C | after TxF (RespAcid & Hypotension) day 3,         |
| 22/99 | .13 | V |                                                   |
|       |     |   | short HFO rescue attempt                          |
+-------+-----+---+---------------------------------------------------+
| 4/    | 1   | H | patient cardiac arrest at 20 minutes, prior to    |
| 19/99 | .15 | F | initiation                                        |
|       |     |   |                                                   |
|       |     |   | of HFO                                            |
+-------+-----+---+---------------------------------------------------+
| 4/    | 8   | H | written Informed Consent not received at time     |
| 26/99 | .02 | F |                                                   |
|       |     |   | of randomization                                  |
+-------+-----+---+---------------------------------------------------+
| 5/    | 7   | H | patient taken off HF @ 6 hrs, returned to HF      |
| 28/99 | .03 | F | after 48 hrs                                      |
+-------+-----+---+---------------------------------------------------+
| 6/    | 9   | C | patient left in SIMV but at 10 cc/kg for first 3  |
| 16/99 | .03 | V | days                                              |
+-------+-----+---+---------------------------------------------------+
| 6/    | 8   | C | on day 3 patient switched to SIMV from PCV        |
| 21/99 | .03 | V |                                                   |
+-------+-----+---+---------------------------------------------------+
| 7/    | 3   | H | patient enrolled with high wedge, but ARDS        |
| 26/99 | .06 | F | present                                           |
+-------+-----+---+---------------------------------------------------+
| 7/    | 3   | H | patient removed from HF early because of          |
| 26/99 | .06 | F |                                                   |
|       |     |   | hyperventilation                                  |
+-------+-----+---+---------------------------------------------------+
| 7/    | 9   | H | patient to OR on CMV twice                        |
| 26/99 | .04 | F |                                                   |
+-------+-----+---+---------------------------------------------------+
| 10/   | 4   | H | Attending switched patient to CMV on day 1        |
| 14/99 | .11 | F | without                                           |
|       |     |   |                                                   |
|       |     |   | Tx failure criteria met                           |
+-------+-----+---+---------------------------------------------------+
| 12/   | 2   | H | Uneventful early wean to CMV on day 4             |
| 15/99 | .15 | F |                                                   |
+-------+-----+---+---------------------------------------------------+
| 7     | 4   | C | Patient switched to another CMV strategy (PCV)    |
| /3/00 | .12 | V |                                                   |
|       |     |   | because of bradycardia                            |
+-------+-----+---+---------------------------------------------------+
| 8/    | 10  | H | Unexplained episode of arrythmia and hypotention, |
| 31/00 | .07 | F |                                                   |
|       |     |   | perhaps related to low pH                         |
+-------+-----+---+---------------------------------------------------+
| 11/   | 9   | H | PEEP \<10 at entry, had grade2 airleak & OI 23    |
| 11/00 | .27 | F |                                                   |
|       |     |   | so ARDS was severe, just low PEEP re:Air leak     |
+-------+-----+---+---------------------------------------------------+
| 11/   | 9   | H | 2 days after wean to CMV, rapid rise in ICP and   |
| 19/00 | .27 | F | death,                                            |
|       |     |   |                                                   |
|       |     |   | likely due to head trauma                         |
+-------+-----+---+---------------------------------------------------+
| 11/   | 7   | H | Patient circuit lost pressure, patient switched   |
| 24/00 | .16 | F | to CMV                                            |
|       |     |   |                                                   |
|       |     |   | and later returned to HF unevenfully              |
+-------+-----+---+---------------------------------------------------+
|       |     |   |                                                   |
+-------+-----+---+---------------------------------------------------+
|       |     |   |                                                   |
+-------+-----+---+---------------------------------------------------+