TerminatedNot Applicable

The Impact of Fluid Volume Shifts on Upper Airway Collapse and Obstructive Sleep Apnea in Surgical Patients

Stopped: lapse of renewal

Canada50 participantsStarted 2019-07-22

Plain-language summary

The objective of this study is to examine the contribution of intravenous (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, 50 consecutive preoperative adult obstructive sleep apnea (OSA) patients, requiring at least one night hospital stay post surgery, will be recruited. 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. 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult patients (\>18 yrs)
✓. Previously diagnosed OSA (AHI \> 10), untreated or non-compliant to treatment, or patients screened as suspected OSA (STOP Bang \>3, and confirmed to have OSA with AHI \> 10 on a portable sleep study)
✓. ASA physical status I - IV
✓. Patients undergoing elective non-cardiac surgery under general anesthesia;
✓. Patients requiring overnight admission.

Exclusion criteria

✕. Patients compliant on OSA treatment such as continuous positive airway pressure therapy or an oral appliance
✕. Vascular surgery on the lower limbs, or metal implants in lower limbs
✕. Pregnant or lactating patients
✕. Cardiac, intra-cranial, or neck procedures.
✕. Inability to communicate: with health care providers or the research personnel, inability to perform breathing maneuvers such as spirometry, or inability to follow instructions.

What they're measuring

Neck, leg and total body water volumes preoperatively and on postoperative night 1 and the morning after surgery

Timeframe: 24 hours

Apnea-hypopnea index on the night of surgery

Timeframe: 24 hours

Trial details

NCT IDNCT03850041

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-14

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials