Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Semi-up Right Position Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152202
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto

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


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: Semi-upright position Other: Supine position Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Semi-upright position
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.
Other: Semi-upright position
In this group patients' bed will be set into 45 degree angle during sleep in the night time.
Other Name: Semi-upright position (45 degree bed angle)

Control group (Supine 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
Other: Supine position
Control: Supine position during nocturnal sleep for at least two postoperative nights.
Other Name: Control group




Primary Outcome Measures :
  1. 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. [ Time Frame: 3days ]
    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 :
  1. 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. [ Time Frame: 30 days ]
    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.

  2. Hospital stay [ Time Frame: 30 days ]
    Length of hospital stay, readmission within 30 days, and patient satisfaction score will be recorded and telephonic interview with the patient on POD30.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152202


Locations
Layout table for location information
Canada, Ontario
Mount Sinai Hospital, Department of Anesthesia
Toronto, Ontario, Canada, M5G 1X5
Toronto Western Hospital, Department of Aneshtesia
Toronto, Ontario, Canada, M5T2S8
University Health Network, Department of Anesthesia
Toronto, Ontario, Canada, M5T2S8
Toronto Western Hospital, Department of Aneshtesia
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Frances Chung, MD University Health Network, Toronto

Layout table for additonal information
Responsible Party: Dr. Frances Chung, Staff Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02152202     History of Changes
Other Study ID Numbers: Protocol version july 17, 2011
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases