NCT00588848

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 27, 2013

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

3.2 years

First QC Date

January 3, 2008

Results QC Date

October 28, 2012

Last Update Submit

January 11, 2019

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea Hypopnea SyndromeOSAPostoperativeCPAP

Outcome Measures

Primary Outcomes (1)

  • Sleep Related Hypoxemia

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

Secondary Outcomes (2)

  • Apnea-Hypopnea Index (AHI)

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

  • Cardiopulmonary Complications

    72 hours

Study Arms (2)

Autoadjusting CPAP (VPAP auto)

EXPERIMENTAL

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)

CPAP arm (usual care)

ACTIVE COMPARATOR

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

Interventions

Autoadjusting CPAP (VPAP Auto)DEVICE

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).

Also known as: VPAP Auto
Autoadjusting CPAP (VPAP auto)
CPAPDEVICE

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

CPAP arm (usual care)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (5)

  • 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.

    PMID: 11991871BACKGROUND

  • 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.

    PMID: 2122773BACKGROUND

  • 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.

    PMID: 9249130BACKGROUND

  • 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.

    PMID: 11560300BACKGROUND

  • 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.

    PMID: 16645462BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Limitations and Caveats

Trial limitations include: 1\. Insufficient enrollment to adequately analyze data

Results Point of Contact

Title
Dr. Dennis Auckley
Organization
MetroHealth Medical Center
dauckley@metrohealth.org
216-778-7212

Study Officials

  • Inderjeet S Brar, MD

    MetroHealth Medical Center, Case Western Reserve University

    PRINCIPAL INVESTIGATOR

  • Dennis Auckley, MD

    MetroHealth Medical Center, Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, CWRU

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 9, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

January 14, 2019

Results First Posted

May 27, 2013

Record last verified: 2019-01

Locations

US(1)