NCT02666781

Postoperative Rostral Fluid Shift and Obstructive Sleep Apnea

Completed Last updated 18 May 2023

What this trial tests

trial testing ApneaLink Plus, BIA Device in Obstructive Sleep Apnea in 50 participants. Completed in 18 June 2018.

Timeline

22 April 2016

Primary endpoint
16 June 2017

18 June 2018

Quick facts

Lead sponsor	University Health Network, Toronto
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	22 April 2016
Primary completion	16 June 2017
Estimated completion	18 June 2018
Sites	1 location across Canada

Drugs / interventions tested

• ApneaLink Plus, BIA Device

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Perioperative trends in neck and leg fluid volume in surgical patients: a prospective observational proof-of-concept study.
   Lukachan GA, Chung F, Yadollahi A, Auckley D, et al · · 2023 · cited 2× · PMID 36450944 · DOI 10.1007/s12630-022-02362-6