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Semi-up Right Position Study

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Semi-upright position
Supine position
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (18 years and above),
  • ASA physical status I to IV,
  • Undergoing elective inpatient surgery with obstructive sleep apnea (as determined by initial screening using STOP-Bang questionnaire and if at high risk (>3 points),
  • Confirmed by an Apnea-hypopnea index (AHI) >5 using a diagnostic home portable polysomnography)

Exclusion Criteria:

  • Patients previously diagnosed as OSA and on continuous positive airway pressure (CPAP) device;
  • Known cervical, shoulder, spine abnormalities, and/or chronic pain predisposing to difficulty in maintaining a sitting position; or
  • Previous intervention for OSA (e.g., uvulopalatopharyngoplasty, bariatric surgery); where sitting position is contraindicated postoperatively such as hip or spine surgery, hemodynamic instability; ambulatory surgery i.e. planned discharge on the same day of surgery.

Sites / Locations

  • Mount Sinai Hospital, Department of Anesthesia
  • Toronto Western Hospital, Department of Aneshtesia
  • University Health Network, Department of Anesthesia
  • Toronto Western Hospital, Department of Aneshtesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Semi-upright position

Control group (Supine position)

Arm Description

Semi-upright position defined as 45 degrees incline from horizontal of the patients bed during nocturnal sleep, for two postoperative nights. Daytime naps will be excluded. A regular pillow may be used by the patients based upon the level of comfort and also to support the head in a neutral position.

In this group patients' bed will be set into Supine/0 degree angle during sleep in the night time. Patient will be managed according to routine care

Outcomes

Primary Outcome Measures

Comparison of worsening of severity of OSA using the Apnea-hypopnea index (AHI) as determined by a portable polysomnography study from baseline (preoperatively) to the second postoperative night.
The AHI is used as a surrogate outcome to establish the diagnosis of OSA (AHI>5) and severity of OSA as per the guidelines from American Academy of Sleep Physicians (AASP).5 It is a continuous outcome and is measured by counting the number of apneas (complete cessation of airflow for more than 10 s) and hypopneas (airflow reduction more than 50%) despite continuing breathing efforts and thus differentiating from central events (absence of breathing efforts). The relationship of AHI to clinical outcomes of relevance has been well established in the literature.

Secondary Outcome Measures

Major and minor perioperative complications and length of hospital stay on postoperative day (POD) 1, POD2, at discharge and POD 30 will be recorded based on chart review.
The oxygen desaturation index; REM sleep related change in AHI at baseline and POD2 and time spent in lateral position while asleep will be deciphered from the PSG data.
Hospital stay
Length of hospital stay, readmission within 30 days, and patient satisfaction score will be recorded and telephonic interview with the patient on POD30.

Full Information

First Posted
May 22, 2014
Last Updated
May 3, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02152202
Brief Title
Semi-up Right Position Study
Official Title
Does a Semi-upright Position During Sleep Prevent Worsening of Severity of Obstructive Sleep Apnea (OSA) on the Second Postoperative Night in Patients Following Elective Inpatient Surgery? A Two Arm, Parallel, Randomized, Controlled, First Stage Proof of Concept Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (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
Our main objective is to perform an explanatory, first stage proof of concept, randomized controlled trial to determine whether a semi-upright patient position versus a supine position while asleep in the postoperative period helps decrease the worsening of AHI in patients diagnosed with OSA and compare this to usual care (i.e. supine patient positioning while asleep). The investigators will evaluate whether a semi-upright position reduces: worsening of AHI (as measured with a portable PSG) on the second postoperative night (POD2); oxygen desaturation index (using a portable oxygen saturation monitor, oxygen desaturation defined as >4% change below baseline lasting for 10 seconds); REM sleep related change in AHI at baseline and POD2.; major and minor perioperative complications on postoperative day POD1, POD2, at discharge and POD 30.; length of hospital stay and readmission within 30 days; and patient satisfaction score on POD30
Detailed Description
The proposed study is to determine whether patient positioning in supine or semi-sitting position can effectively control the worsening of OSA see in the postoperative period. The study patient will be randomized to semi-sitting position (45 degrees incline) group or supine (0 degrees incline) group. Patients will undergo a portable sleep study on the first or second postoperative night. They will also be monitored with wristwatch oximeter pre and postoperatively according to the study protocol. Patients will be managed according to the routine care determined by the health care team. There will be no change in the clinical management of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semi-upright position
Arm Type
Experimental
Arm Description
Semi-upright position defined as 45 degrees incline from horizontal of the patients bed during nocturnal sleep, for two postoperative nights. Daytime naps will be excluded. A regular pillow may be used by the patients based upon the level of comfort and also to support the head in a neutral position.
Arm Title
Control group (Supine position)
Arm Type
Other
Arm Description
In this group patients' bed will be set into Supine/0 degree angle during sleep in the night time. Patient will be managed according to routine care
Intervention Type
Other
Intervention Name(s)
Semi-upright position
Other Intervention Name(s)
Semi-upright position (45 degree bed angle)
Intervention Description
In this group patients' bed will be set into 45 degree angle during sleep in the night time.
Intervention Type
Other
Intervention Name(s)
Supine position
Other Intervention Name(s)
Control group
Intervention Description
Control: Supine position during nocturnal sleep for at least two postoperative nights.
Primary Outcome Measure Information:
Title
Comparison of worsening of severity of OSA using the Apnea-hypopnea index (AHI) as determined by a portable polysomnography study from baseline (preoperatively) to the second postoperative night.
Description
The AHI is used as a surrogate outcome to establish the diagnosis of OSA (AHI>5) and severity of OSA as per the guidelines from American Academy of Sleep Physicians (AASP).5 It is a continuous outcome and is measured by counting the number of apneas (complete cessation of airflow for more than 10 s) and hypopneas (airflow reduction more than 50%) despite continuing breathing efforts and thus differentiating from central events (absence of breathing efforts). The relationship of AHI to clinical outcomes of relevance has been well established in the literature.
Time Frame
3days
Secondary Outcome Measure Information:
Title
Major and minor perioperative complications and length of hospital stay on postoperative day (POD) 1, POD2, at discharge and POD 30 will be recorded based on chart review.
Description
The oxygen desaturation index; REM sleep related change in AHI at baseline and POD2 and time spent in lateral position while asleep will be deciphered from the PSG data.
Time Frame
30 days
Title
Hospital stay
Description
Length of hospital stay, readmission within 30 days, and patient satisfaction score will be recorded and telephonic interview with the patient on POD30.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years and above), ASA physical status I to IV, Undergoing elective inpatient surgery with obstructive sleep apnea (as determined by initial screening using STOP-Bang questionnaire and if at high risk (>3 points), Confirmed by an Apnea-hypopnea index (AHI) >5 using a diagnostic home portable polysomnography) Exclusion Criteria: Patients previously diagnosed as OSA and on continuous positive airway pressure (CPAP) device; Known cervical, shoulder, spine abnormalities, and/or chronic pain predisposing to difficulty in maintaining a sitting position; or Previous intervention for OSA (e.g., uvulopalatopharyngoplasty, bariatric surgery); where sitting position is contraindicated postoperatively such as hip or spine surgery, hemodynamic instability; ambulatory surgery i.e. planned discharge on the same day of surgery.
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
Mount Sinai Hospital, Department of Anesthesia
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto Western Hospital, Department of Aneshtesia
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
University Health Network, Department of Anesthesia
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
Toronto Western Hospital, Department of Aneshtesia
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Semi-up Right Position Study

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