Semi-up Right Position Study

NCT02152202 | Completed

• 1 other identifier: Protocol version july 17, 2011
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 4

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (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.

  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.

  3days

Secondary Outcomes (2)

• 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.

  30 days

• Hospital stay

  30 days

Study Arms (2)

Semi-upright position

EXPERIMENTAL

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

Control group (Supine position)

OTHER

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

Interventions

Semi-upright position OTHER

In this group patients' bed will be set into 45 degree angle during sleep in the night time.

Also known as: Semi-upright position (45 degree bed angle)

Semi-upright position

Supine position OTHER

Control: Supine position during nocturnal sleep for at least two postoperative nights.

Also known as: Control group

Control group (Supine position)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (4)

Mount Sinai Hospital, Department of Anesthesia

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto Western Hospital, Department of Aneshtesia

Toronto, Ontario, M5T2S8, Canada

Location

University Health Network, Department of Anesthesia

Toronto, Ontario, M5T2S8, Canada

Location

Toronto Western Hospital, Department of Aneshtesia

Toronto, Ontario, Canada

Location

Related Publications (1)

• Lukachan GA, Yadollahi A, Auckley D, Gavrilovic B, Matelski J, Chung F, Singh M. The impact of semi-upright position on severity of sleep disordered breathing in patients with obstructive sleep apnea: a two-arm, prospective, randomized controlled trial. BMC Anesthesiol. 2023 Jul 13;23(1):236. doi: 10.1186/s12871-023-02193-y.

  PMID: 37443016 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Supine Position; Control Groups

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Frances Chung, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 4, 2026

Record last verified: 2016-05

Locations

CA (4)