+-----------------------------------------------------------------------+
| .                                                                     |
|                                                                       |
| **Patient ID \# :                                                     |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**                  |
|                                                                       |
| **Center:** WHMC TH WH MMC BMH USF MCMC BAMC                          |
|                                                                       |
| **Randomization:** HFOV Conventional                                  |
|                                                                       |
| date/time \_\_\_ / \_\_\_ /\_\_ @ hrs (24 hour clock)                 |
|                                                                       |
| mm dd yy                                                              |
|                                                                       |
| .                                                                     |
+-----------------------------------------------------------------------+

Inclusion/exclusion criteria confirmed by:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Inclusion Criteria: Exclusion Criteria:**

\_\_ 1. Age ≥ 16 years **and •** FiO~2~ \> .80 for \> 24 hours **or**

\_\_ 2. Weight ≥ 35 kg • persistent airleak **or**

\_\_ 3. P/F ratio \< 200 • nonpulmonary terminal prognosis **or**

on two consecutive ABG's • intractable shock **or**

\> 30 min. apart but \<4 hrs apart **with •** severe COPD or asthma
**or**

\_\_ 4. PEEP ≥ 10 cm H2O **with •** enrollment in another investigation

\_\_ 5. bilateral infiltrates **and** for ARDS or septic shock \< 30
days

\_\_ 6. PA wedge \< 18 mmHg **or**

\_\_ 7. no evidence of LA hypertension **and**

\_\_ 8. ability to gain Informed Consent

**Patient Data**

Gender: M F DOB: \_\_\_ /\_\_\_ /\_\_\_ Age: \_\_\_\_\_

dd mm yy

Height: \_\_\_\_\_ cm Wt: \_\_\_\_\_ kg (ICU Admit)

Intubation

Intubation type: orotracheal \_\_\_ nasotracheal \_\_\_ tracheostomy
\_\_\_

ET diameter: \_\_\_ mm ET length: \_\_\_\_ cm

Number of days of mechanical ventilation prior to randomization
\_\_\_.\_\_\_

Were there any pneumothoraces present at time of randomization? Yes No

Air leak grade: 0 1 2 3 4

Number of days with air leak prior to randomization \_\_\_ .\_\_\_

Note: This form, or the computer randomization screen should be faxed to
Tom Bachman, 909 337-0830 within 48 hours of entering patient in the
study.

**PRE-ENTRY CLINICAL DATA**

**Center \_\_\_\_\_ Patient \# \_\_\_\_\_\_\_\_\_\_\_\_\_**

**APACHE 2** **Score \_\_\_\_\_** (worst values in first 24 hours of
this ICU admission)

**Diagnosis:** (please check all relevant risk groups)

\_\_\_ sepsis

(circle source: pneumonia • intestinal/abdominal • urinary tract •
catheter • other • unknown)

\_\_\_ inhalation injury \_\_\_ trauma (circle: chest or head)

\_\_\_ embolism \_\_\_ aspiration \_\_\_ pulmonary infection \_\_\_ drug
induced

\_\_\_ pancreatitis

 \_\_\_ transfusion related \_\_\_ intravascular coag. \_\_\_ other
(list)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Ventilator Settings/ABG's - Prior to Randomization**

PIP \_\_\_\_\_\_ PEEP \_\_\_\_\_ Mean Paw \_\_\_\_\_ I:E \_\_\_\_\_\_

I-Time \_\_\_\_\_ Resp Rate \_\_\_\_\_\_\_ Tidal volume \_\_\_\_\_

FiO2 \_\_\_\_\_\_\_ Hgb \_\_\_\_\_\_ HCO3 \_\_\_\_\_\_ Base excess
\_\_\_\_

pH \_\_\_\_\_\_ PaO2 \_\_\_\_\_\_ PaCO2 \_\_\_\_\_\_ SaO~2~ \_\_\_\_\_\_

**Cardiovascular Data - Prior to Randomization**

BP (s/d/m) \_\_\_\_\_\_/\_\_\_\_\_\_/\_\_\_\_\_\_ HR \_\_\_\_\_\_ CVP
\_\_\_\_\_\_

PAP \_\_\_\_\_\_/\_\_\_\_\_\_ CO \_\_\_\_\_\_ PCWP\_\_\_\_\_\_

Note: The Ventilator Settings, ABG and Cardiovascular data Prior to
Randomization, should be the data most reflective of the patients status
when randomized.

**VENTILATOR & CLINICAL DATA - during HFOV**

**Center \_\_\_\_\_ Patient \# \_\_\_\_\_\_\_\_\_\_\_\_\_**

+-----------------------+--------------+---+--------------+---+--------------+
| **Scheduled date and  | **\_\_\_\_\_ |   | **\_\_\_\_\_ |   | **\_\_\_\_\_ |
| time**                | \_\_\_\_\_** |   | \_\_\_\_\_** |   | \_\_\_\_\_** |
|                       |              |   |              |   |              |
| **of reading (24 hr   | **\_\_\_ :   |   | **\_\_\_ :   |   | **\_\_\_ :   |
| clock)**              | \_\_\_ hrs** |   | \_\_\_ hrs** |   | \_\_\_ hrs** |
+-----------------------+--------------+---+--------------+---+--------------+
| **Actual date and     | **\_\_\_\_\_ |   | **\_\_\_\_\_ |   | **\_\_\_\_\_ |
| time**                | \_\_\_\_\_** |   | \_\_\_\_\_** |   | \_\_\_\_\_** |
|                       |              |   |              |   |              |
| **(24 hr clock)**     | **\_\_\_ :   |   | **\_\_\_ :   |   | **\_\_\_ :   |
|                       | \_\_\_ hrs** |   | \_\_\_ hrs** |   | \_\_\_ hrs** |
+-----------------------+--------------+---+--------------+---+--------------+
| Bias flow             |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Power setting         |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Delta-P               |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Mean Paw              |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Frequency Hz          |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| \% I-time             |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Hgb                   |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| FiO2                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| pH                    |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| PaCO2                 |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| PaO2                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| HCO3                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| SaO2                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| SvO2                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| heart rate            |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| systolic BP           |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| diastolic BP          |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| mean BP               |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| CVP                   |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Cardiac Output        |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| PCWP                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Air leak score        | 0 1 2 3 4    | 0 |              | 0 |              |
| (circle)              |              | 1 |              | 1 |              |
|                       |              | 2 |              | 2 |              |
|                       |              | 3 |              | 3 |              |
|                       |              | 4 |              | 4 |              |
+-----------------------+--------------+---+--------------+---+--------------+
| ET Tube               |              |   |              |   |              |
| Change(indicate       |              |   |              |   |              |
| change)               |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| **APACHE 2 Score**    |              |   |              |   |              |
|                       |              |   |              |   |              |
| (Day 1,2 and 3 of     |              |   |              |   |              |
| treatment only)       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+

Note: T= 0 for HFOV is defined as when HFOV is initiated. The first data
should be when the patient has stabilized or at 2 hours if still
unstable. After that data, the readings are scheduled for every 8 hours
for the first 72 hours of HFOV and then once per day while the patient
is on mechanical ventilation. After weaning to convention ventilation
these data should be reported on the equivalent "-during Conventional
Ventilation" form CRF-4. This form permits the recording of the
scheduled and actual protocol time.

**VENTILATOR & CLINICAL DATA - during CMV**

**Center \_\_\_\_\_ Patient \# \_\_\_\_\_\_\_\_\_\_\_\_\_**

+-----------------------+--------------+---+--------------+---+--------------+
| **Scheduled date and  | **\_\_\_\_\_ |   | **\_\_\_\_\_ |   | **\_\_\_\_\_ |
| time**                | \_\_\_\_\_** |   | \_\_\_\_\_** |   | \_\_\_\_\_** |
|                       |              |   |              |   |              |
| **of reading (24 hr   | **\_\_\_ :   |   | **\_\_\_ :   |   | **\_\_\_ :   |
| clock)**              | \_\_\_ hrs** |   | \_\_\_ hrs** |   | \_\_\_ hrs** |
+-----------------------+--------------+---+--------------+---+--------------+
| **Actual date and     | **\_\_\_\_\_ |   | **\_\_\_\_\_ |   | **\_\_\_\_\_ |
| time**                | \_\_\_\_\_** |   | \_\_\_\_\_** |   | \_\_\_\_\_** |
|                       |              |   |              |   |              |
| **(24 hr clock)**     | **\_\_\_ :   |   | **\_\_\_ :   |   | **\_\_\_ :   |
|                       | \_\_\_ hrs** |   | \_\_\_ hrs** |   | \_\_\_ hrs** |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| PIP                   |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| PEEP                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Mean Paw              |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| I:E                   |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Rate                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Tidal Volume (ml)     |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Hgb                   |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| FiO2                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| pH                    |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| PaCO2                 |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| PaO2                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| HCO3                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| SaO2                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| SvO2                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| heart rate            |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| systolic BP           |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| diastolic BP          |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| mean BP               |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| CVP                   |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Cardiac Output        |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| PCWP                  |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| Air Leak Score        | 0 1 2 3 4    | 0 |              | 0 |              |
| (circle)              |              | 1 |              | 1 |              |
|                       |              | 2 |              | 2 |              |
|                       |              | 3 |              | 3 |              |
|                       |              | 4 |              | 4 |              |
+-----------------------+--------------+---+--------------+---+--------------+
| ET Tube               |              |   |              |   |              |
| Change(indicate       |              |   |              |   |              |
| change)               |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
|                       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+
| APACHE II Score       |              |   |              |   |              |
|                       |              |   |              |   |              |
| (Day 1,2 and 3 of     |              |   |              |   |              |
| treatment only)       |              |   |              |   |              |
+-----------------------+--------------+---+--------------+---+--------------+

Note: T= 0 for CV is defined as 1 hour after randomization. The first
data is scheduled for when the patient has stabilized or at 2 hours if
still unstable. After that data the readings are scheduled to occur
every 8 hours for the first 72 hours of CV and then once per day while
the patient is on mechanical ventilation. This form permits the
recording of the scheduled and actual protocol time.

**STUDY EXIT REPORT**

**Center \_\_\_\_\_ Patient \# \_\_\_\_\_\_\_\_\_\_\_\_\_**

**Exit** date/time \_\_\_ / \_\_\_ /\_\_ @ hrs (24 hour clock)

mm dd yy

Exit Criteria met:

\_\_\_ withdrawal of informed consent

\_\_\_ weaned from MV

\_\_\_ 30 days from entry

\_\_\_ HFOV treatment failure and physician determined potential benefit
of CMV

\_\_\_ death (briefly describe cause of death)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Associated Causes of Death: (please select all appropriate causes)

\_\_\_ profound hypoxemia \_\_\_ multiple organ failure
([\>]{.underline} 3 organs)

\_\_\_ sepsis \_\_\_ withdrawal of life support

\_\_\_ cardiac arrhythmia \_\_\_ other:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ (please specify)

**Treatment Failure Criteria Met During Study**

\_\_\_ No

\_\_\_ Yes \_\_\_ / \_\_\_ /\_\_ @ hrs (24 hour clock)

mm dd yy

Criteria Met

> intractable hypotension (average MAP during period)
>
> \_\_\_ MAP \< 50 for 1 hour
>
> \_\_\_ MAP \< 60 for 4 hours
>
> \_\_\_ intractable respiratory failure (pH \< 7.15 and HCO3 \>19 meq/l
> for 6 hours)
>
> \_\_\_ oxygenation failure (OI \> 42 after 72 hours of treatment)

­­­

**OUTCOME REPORT - 1 Month Follow-Up**

**Center \_\_\_\_\_ Patient \# \_\_\_\_\_\_\_\_\_\_\_\_\_**

Indicate source of follow up data

\_\_\_ Patient died (\_\_\_ / \_\_\_ /\_\_ )

dd mm yy

\_\_\_ Actual 30 day follow-up

\_\_\_ Lost to follow-up

i.e. Status at discharge date of discharge (\_\_\_ / \_\_\_ /\_\_ )

dd mm yy

If alive indicate respiratory status

\_\_\_ No respiratory support required

> \_\_\_ Oxygen required - defined as requiring supplemental O2
> administration to maintain an oxygen saturation of at least 90% awake
> without CPAP.
>
> \_\_\_ CPAP required - defined as CPAP required to maintain an oxygen
> saturation of 90% or greater, awake breathing room air.
>
> \_\_\_ Mechanical ventilation required - defined as being required if
> necessary to maintain a PaCO2 of ≤ 50 Torr during spontaneous
> breathing with metabolic acidosis treated (HCO3\> 19 meq/L).

**Other significant events**

\_\_\_ Weaned MV: (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

\_\_\_ Weaned O2: (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

\_\_\_ Discharged: (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

\_\_\_ Transferred: (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

\_\_\_ Extraordinary therapeutic interventions after exit ? (e.g., ECMO,
iNO, HFV, other)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**OUTCOME REPORT - 6 Month Follow-Up**

**Center \_\_\_\_\_ Patient \# \_\_\_\_\_\_\_\_\_\_\_\_\_**

Indicate source of follow up data

\_\_\_ Patient died (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

\_\_\_ Actual 6 month follow-up

\_\_\_ Lost to follow-up

\_\_\_ Status at discharge date of discharge (\_\_\_ / \_\_\_ /\_\_ )

dd mm yy

\_\_\_ Status at 30 days

If alive indicate respiratory status

\_\_\_ No respiratory support required

> \_\_\_ Oxygen required - defined as requiring supplemental O2
> administration to maintain an oxygen saturation of at least 90% awake
> without CPAP.
>
> \_\_\_ CPAP required - defined as CPAP required to maintain an oxygen
> saturation of 90% or greater, awake breathing room air.
>
> \_\_\_ Mechanical ventilation required - defined as being required if
> necessary to maintain a PaCO2 of ≤ 50 Torr during spontaneous
> breathing with metabolic acidosis treated (HCO3\> 19 meq/L).

**Other significant events**

\_\_\_ Weaned MV: (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

\_\_\_ Weaned O2: (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

\_\_\_ Discharged: (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

\_\_\_ Transferred: (\_\_\_ / \_\_\_ /\_\_ )

mm dd yy

# \_\_\_ Extraordinary therapeutic interventions after exit (e.g., ECMO, iNO, HFV, other) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

# 

# MOAT - UNANTICIPATED EVENT REPORT 

#  FAX 714 283-8493 or

**909 337-0830**

att: Tom Bachman

# PATIENT NUMBER \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

SITE **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

DATE OF EVENT **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

TIME OF EVENT **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

Investigators are required to report any unanticipated events to the
study sponsor within 24 hours of occurrence. This should be accomplished
by filling out this form and faxing it to SensorMedics. After fax
transmission this original form should be maintained with the other Case
Report Forms.

These reportable events include: 1) HFOV failure, 2) study protocol
violation, and 3) unanticipated adverse clinical events. (note the study
Risk Analysis anticipates certain potential adverse effects that need
not be reported on this form including: pulmonary overdistention,
barotrauma, excess mucus, and over or under oxygenation and ventilation)

INDICATE TYPE OF EVENT

\_\_\_\_ HFOV failure, \_\_\_\_ protocol violation, \_\_\_\_
unanticipated adverse clinical event

  -----------------------------------------------------------------------
  DESCRIBE EVENT

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

INVESTIGATOR SUBMITTING REPORT
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

V**VENTILATOR STRATEGY LOG**

**Center \_\_\_\_\_ Patient \# \_\_\_\_\_\_\_\_\_\_\_\_\_**

+-----------+---------------+------------------------------------------+
| Date &    | Ventilator    | Reason for change                        |
| Time      | change        |                                          |
|           |               | (e.g., O2 sat 85%)                       |
| (2/13 -   | (e.g., PEEP   |                                          |
| 22:12)    | 12 to 15)     |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+
|           |               |                                          |
+-----------+---------------+------------------------------------------+

note: Keep with ventilator and document every significant ventilator
setting change for the first three days of treatment on the assigned
ventilator or until exit, whichever occurs first.

**ELIGIBILITY LOG**

**Center \_\_\_\_\_**

+------+---------+----------+----------------------------------------+
| Date | Patient | P/F &    | Reason for not enrolling               |
|      | ID      | PEEP     |                                        |
| (m/d |         |          | (eg, no Informed Consent, Investigator |
| /yy) |         | (eg. 95  | unavailable,                           |
|      |         | / 12)    |                                        |
|      |         |          | not ARDS, HFOV unavailable)            |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+
|      |         |          |                                        |
+------+---------+----------+----------------------------------------+

Confounding Therapies

# Center \_\_\_\_\_\_ Patient \# \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**1. Entry through day 30 days**

+------------+-------------+------------+--------------+--------------+
| Treatment  | Received ?  | #          | Length       | Responded ?  |
|            |             |  Study Day |              |              |
|            |             |            |              |              |
|            |             | s          |              |              |
|            |             | tarted\*\* |              |              |
+------------+-------------+------------+--------------+--------------+
| ECMO       | yes no      |            |              | yes no       |
+------------+-------------+------------+--------------+--------------+
| iNO        | yes no      |            |              | yes no       |
+------------+-------------+------------+--------------+--------------+
| Proning    | yes no      |            |              | yes no       |
+------------+-------------+------------+--------------+--------------+
| Steriods   | yes no      |            |              | yes no       |
| \*         |             |            |              |              |
+------------+-------------+------------+--------------+--------------+
| Surfactant | yes no      |            |              | yes no       |
+------------+-------------+------------+--------------+--------------+
| HFV \*\*\* | yes no      |            |              | yes no       |
+------------+-------------+------------+--------------+--------------+

\* only Steriods for treatment of fibro-proliferative phase of ARDS need
be noted. If yes, indicate below the initial dose and duration

(e.g., initial 2 mg/kg/day m-prednisolone for 14 days).

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\*\* day 1 - 30 even if patient already exited from study

\*\*\* HFV used for rescue (indicate HFO or HFJ)

**2. Prior to entry:**

• patient immune compromised ? Y N

• extended mechanical ventilation (5 days or greater) ? Y N

If yes:

\- P/F \< 200 with PEEP 10 or greater for \_\_\_ . \_\_\_ days

\- Bilateral infiltrates for \_\_\_ . \_\_\_ days