The Effectiveness of Perioperative CPAP to Reduce Obstructive Sleep Apnea Related Adverse Events

NCT01249924 | Completed

• 1 other identifier: 0000
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients with moderate and severe OSA.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index

  Apnea-hypopnea index.

  On the third night after surgery

Secondary Outcomes (1)

• Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90)

  2-3 nights before surgery and 5 nights after surgery

Study Arms (2)

CPAP Group

OTHER

CPAP Treatment

Device: auto-titrated CPAP

Control Group

OTHER

Routine care

Device: auto-titrated CPAP; Device: Control

Interventions

auto-titrated CPAP DEVICE

Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.

CPAP Group; Control Group

Control DEVICE

Patients in this group will receive routine care, undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for oxygen saturation level for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the patients who meet the following criteria will be recruited
• Patients who are scheduled for inpatient surgery that required a minimum of three nights of hospital stay
• Age: \>18 and \<80 years old.
• Identified as high risk of having OSA or diagnosed with OSA without using CPAP.

You may not qualify if:

• Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery.
• Unwilling or unable to give informed consent.
• Currently undergoing treatment for sleep apnea including CPAP.
• Requiring prolonged postoperative ventilation.
• New York Heart Association functional class III and IV.
• Having valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina.
• Having myocardial infarction or cardiac surgery within 3 months.
• Having chronic obstructive pulmonary disease, or asthma.
• Having a presence of tracheostomy, facial, neck, or chest wall abnormalities.
• Having abdominal aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months.
• Visiting preoperative clinic less than 3 days before scheduled surgery date.
• On nasogastric tube postoperatively.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Toronto Western Hospital, Department of Aneshtesia

Toronto, Ontario, M5T2S8, Canada

Location

Mount Sinai Hospital, Department of Anesthesia

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Frances Chung, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 26, 2010
• First Posted: November 30, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 18, 2013

Record last verified: 2012-07

Locations

CA (2)