CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
ApneaLink Plus, BIA Deviceother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02666781
NCT02666781N/ACompleted

The Contribution of Rostral Shift of Fluid to Postoperative Worsening of Obstructive Sleep Apnea Severity in Surgical Patients - A Prospective Cohort Study

University Health Network, Toronto·observational·Posted Jan 28, 2016·Updated May 18, 2023

In Brief

An observational study evaluating ApneaLink Plus, BIA Device for Obstructive Sleep Apnea. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Patients with obstructive sleep apnea (OSA) are more likely to experience postoperative complications and impact significantly on healthcare resources. In the surgical population, the type and volume of IV fluid administration may contribute to the worsening of postoperative sleep apnea but the pathophysiological mechanisms have not been elucidated. Recent research from general population suggests that intravenous (IV) fluid administration worsens the severity of OSA by shifting of fluid from the legs to the neck thus increasing neck size and causing airway collapse. In this novel study, our objective is to examine the contribution of IV fluid administration and rostral fluid shift from the legs to the neck thereby leading to worsening of sleep apnea following surgery. In this prospective observational cohort study, 25 consecutive adult patients, requiring at least 2 days hospital stay, will be recruited. Following informed consent, patients will undergo portable home sleep study to determine the preoperative severity of sleep-disordered breathing. On the day of surgery, leg, neck and total body fluid volumes will be recorded, and patients will undergo general anesthetic. The results of this study will be used to design future clinical trials evaluating methods to decrease postoperative OSA worsening, as well as decreasing OSA-related postoperative complications.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 28, 2016
Enrollment StartApr 22, 2016
Primary CompletionJun 16, 2017
Study CompletionJun 18, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.4 years ago

Interventions

ApneaLink Plus, BIA Deviceother

The study is only observational. No interventions will be performed. ApneaLink Plus will be used to diagnose Obstructive Sleep Apnea in potential candidates and grade its severity on Postoperative night 2 in participants. A BIA Device will be used to detect segmental fluid shifts. A 3-D accelerometer will be used to detect head and neck position.