NCT01552304

Brief Summary

Hypotheses:

  1. 1.Postoperative oxygen therapy significantly improves postoperative oxygenation in OSA surgical patients.
  2. 2.Postoperative oxygen therapy do not significantly increase the number of apnea episodes and the duration of apnea episodes.
  3. 3.Postoperative oxygen therapy do not significantly increase arterial carbon dioxide(CO2) level in OSA surgical patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2016

Enrollment Period

5.2 years

First QC Date

March 6, 2012

Last Update Submit

May 3, 2017

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaOxygen therapySurgeryAnesthesia

Outcome Measures

Primary Outcomes (3)

  • Pulse oxygen saturation

    Nocturnal oxygen desaturation index and percentage of time with SaO2\<90% on postoperative night 1 to 3.

    3 nights postoperatively

  • Sleep disordered breathing

    Including apnea hypopnea index, obstructive apnea index, central apnea index, hypopnea index, respiratory arousal index, and average and longest duration for obstructive, central and mixed apnea episodes, and hypopnea episodes on postoperative night 3.

    Postoperative night 3 only

  • Blood CO2 level

    Transcutaneous CO2 level on postoperative night 1-3.

    postoperative night1 to noght 3

Secondary Outcomes (1)

  • perioperative clinical adverse events

    30 days after surgery

Study Arms (2)

Oxygen treatment group

EXPERIMENTAL

Besides routine care, patients in this group will receive postoperative oxygen therapy with nasal prolong at 3 liters/min during the first 3 nights after surgery.

Other: Oxygen therapy

Control group

OTHER

Patients will be managed by the anesthesiologists and surgeons as per routine practice.

Other: Control group

Interventions

Oxygen therapyOTHER

Besides perioperative routine care provided by anesthesiologists and surgeons, patients will receive postoperative oxygen supplementation with nasal prolong at 3 liters/min during the first 3 nights after surgery.

Oxygen treatment group
Control groupOTHER
Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are scheduled for inpatient surgery that requires a minimum of three nights of hospital stay
  • Age: 18 to 80 years old.
  • Identified as high risk of having OSA or diagnosed with OSA but not 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.
  • Requiring prolonged postoperative ventilation.
  • Having chronic obstructive pulmonary disease,
  • HCO3 ≥30.
  • Visiting preoperative clinic \< 1day before scheduled surgical date.
  • Having tracheotomy, facial, neck, or chest wall abnormalities.
  • Currently receiving treatment for sleep apnea including CPAP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital, Department of Aneshtesia

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (1)

  • Liao P, Wong J, Singh M, Wong DT, Islam S, Andrawes M, Shapiro CM, White DP, Chung F. Postoperative Oxygen Therapy in Patients With OSA: A Randomized Controlled Trial. Chest. 2017 Mar;151(3):597-611. doi: 10.1016/j.chest.2016.12.005. Epub 2016 Dec 19.

    PMID: 28007620DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

OxygenControl Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Frances Chung, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 13, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 4, 2017

Record last verified: 2016-05

Locations

CA(1)