Oxygen Supplementation Study in Obstructive Sleep Apnea (OSA) Patients

The Benefit and Risk of Oxygen Supplementation in Perioperative Management of Obstructive Sleep Apnea

Hypotheses:

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Control group; Other: Oxygen therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T2S8
      • Toronto Western Hospital, Department of Aneshtesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxygen treatment group; 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; 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.
Other: Control group; Patients will be managed by the anesthesiologists and surgeons as per routine practice.	Other: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative clinical adverse events	Occurrence of perioperative clinical adverse events, especially cardiopulmonary adverse events.Intensive Care Unit(ICU) admission and ICU stay	30 days after surgery

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Frances Chung, MD, University Health Network, Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Surgery; Oxygen therapy; Anesthesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Protocol version May 30, 2011