Obstructive Sleep ApneaNCT01552304
Oxygen Supplementation Study in Obstructive Sleep Apnea (OSA) Patients
A study testing Oxygen therapy in people with Obstructive Sleep Apnea, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, Department of Aneshtesia
Toronto, Ontario, M5T2S8
About this study
Official title: The Benefit and Risk of Oxygen Supplementation in Perioperative Management of Obstructive Sleep Apnea
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Oxygen therapy, Control group
- Keywords
- Obstructive sleep apnea, Oxygen therapy, Surgery, Anesthesia
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control groupOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Oxygen therapy |
| Control group | Other | Patients will be managed by the anesthesiologists and surgeons as per routine practice. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oxygen saturation
Nocturnal oxygen desaturation index and percentage of time with SaO2<90% on postoperative night 1 to 3.
Measured: 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.
Measured: Postoperative night 3 only
Blood CO2 level
Transcutaneous CO2 level on postoperative night 1-3.
Measured: postoperative night1 to noght 3
Secondary outcomes (1)
perioperative clinical adverse events
Occurrence of perioperative clinical adverse events, especially cardiopulmonary adverse events.Intensive Care Unit(ICU) admission and ICU stay
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frances Chung, University Health Network, Toronto
- Investigators
- Frances Chung, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552304
- Sponsor's protocol ID
- Protocol version May 30, 2011
- Status last verified
- May 2016
- First submitted
- 6 Mar 2012
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28007620
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit and Risk of Oxygen Supplementation in Perioperative Management of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01552304
- Acronym / sponsor ID
- Protocol version May 30, 2011
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Oxygen therapy, Surgery, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen treatment group | Experimental | Other: Oxygen therapyBesides 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. |
| Control group | Other | Other: Control groupPatients will be managed by the anesthesiologists and surgeons as per routine practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen therapyBesides 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 | Oxygen treatment group |
| Control group | Other | Control group |
Primary outcome
Pulse oxygen saturation
Time frame: 3 nights postoperatively
Nocturnal oxygen desaturation index and percentage of time with SaO2<90% on postoperative night 1 to 3.
Sleep disordered breathing
Time frame: Postoperative night 3 only
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
Time frame: postoperative night1 to noght 3
Transcutaneous CO2 level on postoperative night 1-3.
1 secondary outcome
perioperative clinical adverse events
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Derived from this study: PubMed 28007620Liao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Chung, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen therapy in people with Obstructive Sleep Apnea, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse oxygen saturation (time frame: 3 nights postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01552304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.