CPAP vs AutoCPAP for Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting

• ClinicalTrials.gov Identifier: NCT00588848
• Recruitment Status: Terminated
• First Posted: January 9, 2008
• Results First Posted: May 27, 2013
• Last Update Posted: January 14, 2019
• Sponsor: MetroHealth Medical Center
• Collaborators: ResMed; Great Lakes NeuroTechnologies Inc.
• Information provided by (Responsible Party): Dennis Auckley, MD, MetroHealth Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Device: Autoadjusting CPAP (VPAP Auto); Device: CPAP	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial
• Study Start Date: January 2008
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: April 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Autoadjusting CPAP (VPAP auto); The intervention will be the use of an Autoadjusting CPAP unit that will be applied to the subject during the 8 hours overnight the first night after surgery (study night). During this time, they will undergo a full night attended polysomnogram in their hospital room.	Device: Autoadjusting CPAP (VPAP Auto); An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery).; Other Name: VPAP Auto
Active Comparator: CPAP arm (usual care); The intervention will be the use of the subject's own CPAP machine and this will be applied to the subject during the 8 hours overnight the first after surgery (study night). During the study night, they will undergo full polysomnography in their hospital room.	Device: CPAP; Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)

Outcome Measures

Primary Outcome Measures :

1. Sleep Related Hypoxemia [ Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. ]

Secondary Outcome Measures :

1. Apnea-Hypopnea Index (AHI) [ Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. ]
   Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and >= 30 events/hr = severe
2. Cardiopulmonary Complications [ Time Frame: 72 hours ]
   Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Sponsors and Collaborators

MetroHealth Medical Center

ResMed

Great Lakes NeuroTechnologies Inc.

Investigators

• Principal Investigator: Inderjeet S Brar, MD; MetroHealth Medical Center, Case Western Reserve University
• Principal Investigator: Dennis Auckley, MD; MetroHealth Medical Center, Case Western Reserve University

More Information

Publications:

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. Review.

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.

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. Review.

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.

Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Coté 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.

• Responsible Party: Dennis Auckley, MD, Associate Professor of Medicine, CWRU, MetroHealth Medical Center
• ClinicalTrials.gov Identifier: NCT00588848
• Other Study ID Numbers: IRB07-00504
• First Posted: January 9, 2008
• Results First Posted: May 27, 2013
• Last Update Posted: January 14, 2019
• Last Verified: January 2019

Keywords provided by Dennis Auckley, MD, MetroHealth Medical Center:

Obstructive Sleep Apnea Hypopnea Syndrome; OSA; Postoperative; CPAP

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases