Clinical trial NCT00588848: CPAP vs AutoCPAP for Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting
Official title: Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea Hypopnea Syndrome
OSA
Postoperative
CPAP
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: ResMed
name: Great Lakes NeuroTechnologies Inc.
First posted: 2008-01-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.

Detailed description: The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.

Patients with known Obstructive Sleep Apnea who are on CPAP therapy at home and undergo an elective surgery (meeting specified inclusion and exclusion criteria) will be randomized to either using Autoadjusting CPAP vs their usual CPAP at their prescribed settings the night after surgery. During that night, they will be monitored with full polysomnography in their hospital bed.

Eligibility criteria: Inclusion Criteria:

1. Known OSA patients well-controlled by CPAP (not hypoxemic i.e. Oxygen Saturation (SaO2) ≥ 89% and post-treatment Apnea Hypopnea (AHI) \<10) and compliant ( \> 3 hours per night) presenting for elective inpatient surgery to MetroHealth Medical Center
2. Elective extremity or lower abdominal surgery
3. Age \>18 years

Exclusion Criteria:

1. Surgery that may cause hypoxemia from causes other than the effect on upper airway patency e.g. any thoracic surgery, upper abdominal surgery, head and neck surgery.
2. Surgery on the upper-airway.
3. Any condition that may interfere with application of CPAP mask e.g. trauma, surgery on the face, vomiting, naso-gastric intubation etc.
4. OSA treated with a device other than CPAP e.g. Bilevel positive pressure or V-Positive Airway Pressure
5. OSA needing very high levels of CPAP i.e. \> 16 cms to achieve adequate control
6. OSA or other underlying cardiopulmonary conditions that require supplemental oxygen
7. Patients with decompensated congestive heart failure or advanced Chronic Obstructive Pulmonary Disease (COPD) (FEV1\<35% of predicted)
8. Patients with neuromuscular impairment
9. Patients with central sleep apnea
10. Pregnant patients
11. Decisional impaired subjects who are not able to consent

Primary outcomes:
measure: Sleep Related Hypoxemia
timeFrame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
Secondary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
measure: Cardiopulmonary Complications
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center, Case Western Reserve University
name: Inderjeet S Brar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MetroHealth Medical Center, Case Western Reserve University
name: Dennis Auckley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
citation: Bailey PL, Pace NL, Ashburn MA, Moll JW, East KA, Stanley TH. Frequent hypoxemia and apnea after sedation with midazolam and fentanyl. Anesthesiology. 1990 Nov;73(5):826-30. doi: 10.1097/00000542-199011000-00005.
citation: Ostermeier AM, Roizen MF, Hautkappe M, Klock PA, Klafta JM. Three sudden postoperative respiratory arrests associated with epidural opioids in patients with sleep apnea. Anesth Analg. 1997 Aug;85(2):452-60. doi: 10.1097/00000539-199708000-00037. No abstract available.
citation: Gupta RM, Parvizi J, Hanssen AD, Gay PC. Postoperative complications in patients with obstructive sleep apnea syndrome undergoing hip or knee replacement: a case-control study. Mayo Clin Proc. 2001 Sep;76(9):897-905. doi: 10.4065/76.9.897.
citation: Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.