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

Primary Purpose

Obstructive Sleep Apnea

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Autoadjusting CPAP (VPAP Auto)

CPAP

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea Hypopnea Syndrome, OSA, Postoperative, CPAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Elective extremity or lower abdominal surgery
Age >18 years

Exclusion Criteria:

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.
Surgery on the upper-airway.
Any condition that may interfere with application of CPAP mask e.g. trauma, surgery on the face, vomiting, naso-gastric intubation etc.
OSA treated with a device other than CPAP e.g. Bilevel positive pressure or V-Positive Airway Pressure
OSA needing very high levels of CPAP i.e. > 16 cms to achieve adequate control
OSA or other underlying cardiopulmonary conditions that require supplemental oxygen
Patients with decompensated congestive heart failure or advanced Chronic Obstructive Pulmonary Disease (COPD) (FEV1<35% of predicted)
Patients with neuromuscular impairment
Patients with central sleep apnea
Pregnant patients
Decisional impaired subjects who are not able to consent

Sites / Locations

MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autoadjusting CPAP (VPAP auto)

CPAP arm (usual care)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sleep Related Hypoxemia

Secondary Outcome Measures

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

Cardiopulmonary Complications

Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke

Full Information

NCT ID

NCT00588848

First Posted

January 3, 2008

Last Updated

January 11, 2019

Sponsor

MetroHealth Medical Center

Collaborators

ResMed, Great Lakes NeuroTechnologies Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00588848

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Terminated

Why Stopped

Difficulty with enrollment

Study Start Date

January 2008 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MetroHealth Medical Center

Collaborators

ResMed, Great Lakes NeuroTechnologies Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea Hypopnea Syndrome, OSA, Postoperative, CPAP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autoadjusting CPAP (VPAP auto)

Arm Type

Experimental

Arm Description

Arm Title

CPAP arm (usual care)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Autoadjusting CPAP (VPAP Auto)

Other Intervention Name(s)

VPAP Auto

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

CPAP

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Apnea-Hypopnea Index (AHI)

Description

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

Time Frame

On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.

Title

Cardiopulmonary Complications

Description

Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Elective extremity or lower abdominal surgery Age >18 years Exclusion Criteria: 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. Surgery on the upper-airway. Any condition that may interfere with application of CPAP mask e.g. trauma, surgery on the face, vomiting, naso-gastric intubation etc. OSA treated with a device other than CPAP e.g. Bilevel positive pressure or V-Positive Airway Pressure OSA needing very high levels of CPAP i.e. > 16 cms to achieve adequate control OSA or other underlying cardiopulmonary conditions that require supplemental oxygen Patients with decompensated congestive heart failure or advanced Chronic Obstructive Pulmonary Disease (COPD) (FEV1<35% of predicted) Patients with neuromuscular impairment Patients with central sleep apnea Pregnant patients Decisional impaired subjects who are not able to consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Inderjeet S Brar, MD

Organizational Affiliation

MetroHealth Medical Center, Case Western Reserve University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dennis Auckley, MD

Organizational Affiliation

MetroHealth Medical Center, Case Western Reserve University

Official's Role

Principal Investigator

Facility Information:

Facility Name

MetroHealth Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11991871

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.

Results Reference

background

PubMed Identifier

2122773

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.

Results Reference

background

PubMed Identifier

9249130

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.

Results Reference

background

PubMed Identifier

11560300

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.

Results Reference

background

PubMed Identifier

16645462

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.

Results Reference

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

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