Oxygen Supplementation Study in Obstructive Sleep Apnea (OSA) Patients
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxygen therapy
Control group
Sponsored by
About this trial
This is an interventional health services research trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Oxygen therapy, Surgery, Anesthesia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Toronto Western Hospital, Department of Aneshtesia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Oxygen treatment group
Control group
Arm Description
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.
Patients will be managed by the anesthesiologists and surgeons as per routine practice.
Outcomes
Primary Outcome Measures
Pulse oxygen saturation
Nocturnal oxygen desaturation index and percentage of time with SaO2<90% on postoperative night 1 to 3.
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.
Blood CO2 level
Transcutaneous CO2 level on postoperative night 1-3.
Secondary Outcome Measures
perioperative clinical adverse events
Occurrence of perioperative clinical adverse events, especially cardiopulmonary adverse events.Intensive Care Unit(ICU) admission and ICU stay
Full Information
NCT ID
NCT01552304
First Posted
March 6, 2012
Last Updated
May 3, 2017
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01552304
Brief Title
Oxygen Supplementation Study in Obstructive Sleep Apnea (OSA) Patients
Official Title
The Benefit and Risk of Oxygen Supplementation in Perioperative Management of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypotheses:
Postoperative oxygen therapy significantly improves postoperative oxygenation in OSA surgical patients.
Postoperative oxygen therapy do not significantly increase the number of apnea episodes and the duration of apnea episodes.
Postoperative oxygen therapy do not significantly increase arterial carbon dioxide(CO2) level in OSA surgical patients.
Detailed Description
When patients visit the preoperative clinic for their scheduled surgery, the study coordinator will talk to patients. If they are interested in the study, he/she will ask the patient to answer a couple of questionnaires to see if the patient is qualified for the study. Patients will be asked to answer the STOP-Bang questionnaire to find out if patient is at high risk for sleep apnea. If the result shown that patient are at high risk for sleep apnea, the study coordinator will explain the study to you in detail and go over the consent form. The coordinator will answer all questions patient may have. If patient give consent to participate the study; the coordinator will schedule a sleep study with a sleep monitor at patient home at a convenient time before surgery. After telephone confirmation, the sleep technician will visit your home on the evening of scheduled date to set up the sleep study monitor and a device to measure the blood oxygen level. It would take 20~25 minutes to hook up for over night sleep study. The sleep technician will visit patient's again the next morning to pick up the devices. The recordings of sleep study will be scored by a certified sleep technologist. As a study participant, patient will be randomly (by chance) assigned into one of the following groups:
Control group: Patients will be managed by the anesthesiologists and surgeons as per routine practice.
Oxygen therapy group: Besides during surgical procedure routine care provided by anesthesiologists and surgeons, patients will receive postoperative oxygen supplementation with nasal prong (through nostril) at 3 liters/ min during the first 3 nights after surgery.
Regardless what group patients are in, their blood oxygen saturation will be monitored by a pulse oximeter for 1 night preoperatively and 3 nights postoperatively during their sleep. The blood carbon dioxide will be monitored for first 2 postoperative nights with a portable transcutaneous CO2 device (TCM400). On the third postoperative night, all study patients will also be monitored simultaneously by a portable carbon dioxide device(TCM400) and portable sleep device. For carbon dioxide monitoring, a probe will be attached to patient's arm which is connected to a portable device placed besides patient's bed. Our research staff will hook up the device and remove it from patient.
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, Oxygen therapy, Surgery, Anesthesia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
Patients will be managed by the anesthesiologists and surgeons as per routine practice.
Intervention Type
Other
Intervention Name(s)
Oxygen therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Primary Outcome Measure Information:
Title
Pulse oxygen saturation
Description
Nocturnal oxygen desaturation index and percentage of time with SaO2<90% on postoperative night 1 to 3.
Time Frame
3 nights postoperatively
Title
Sleep disordered breathing
Description
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.
Time Frame
Postoperative night 3 only
Title
Blood CO2 level
Description
Transcutaneous CO2 level on postoperative night 1-3.
Time Frame
postoperative night1 to noght 3
Secondary Outcome Measure Information:
Title
perioperative clinical adverse events
Description
Occurrence of perioperative clinical adverse events, especially cardiopulmonary adverse events.Intensive Care Unit(ICU) admission and ICU stay
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances Chung, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital, Department of Aneshtesia
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28007620
Citation
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.
Results Reference
derived
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Oxygen Supplementation Study in Obstructive Sleep Apnea (OSA) Patients
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