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

Obstructive Sleep Apnea Clinical Trial

Official title:

Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00588848
• Other study ID #: IRB07-00504
• Status: Terminated
• Phase: N/A
• Start date: January 2008
• Est. completion date: April 2011

Study information

• Verified date: January 2019
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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).
• CPAP
Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Great Lakes NeuroTechnologies Inc., ResMed

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Related Hypoxemia		On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
Secondary	Apnea-Hypopnea Index (AHI)	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	On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
Secondary	Cardiopulmonary Complications	Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke	72 hours