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

NCT03850041 | Terminated DMC

• 1 other identifier: 18-5747
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

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

  Measurement of the leg fluid, neck fluid and total body water using the bioelectrical impedance analysis.

  24 hours

• Apnea-hypopnea index on the night of surgery

  Measurement of the AHI (Apnea-hypopnea index) events/hour ,to determine severity of Obstructed Sleep Apnoea on the night of the surgery, using the following scale for ApneaLink device data: 1. No OSA( AHI: 0-5 events/hour), 2. Mild OSA(AHI: 6 to 15 events/hour), 3. Moderate OSA (AHI : 16-30 events/hour) and 4. Severe OSA (AHI: \>30 events/hour),

  24 hours

Secondary Outcomes (1)

• Neck Circumference on Postoperative Night 1

  24 hours

Eligibility Criteria

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

Study Population

Surgical patients attending the preoperative assessment clinic in Toronto Western Hospital (UHN) who will be undergoing elective non-cardiac surgery, requiring general anesthesia, lasting for 1-2 hours or more and requiring same day admission for a minimum of 2 days postoperatively.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Lung Association: collaborator

Study Sites (2)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (5)

• Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.

  PMID: 11254524 BACKGROUND

• Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.

  PMID: 18431116 RESULT

• Mutter TC, Chateau D, Moffatt M, Ramsey C, Roos LL, Kryger M. A matched cohort study of postoperative outcomes in obstructive sleep apnea: could preoperative diagnosis and treatment prevent complications? Anesthesiology. 2014 Oct;121(4):707-18. doi: 10.1097/ALN.0000000000000407.

  PMID: 25247853 RESULT

• Ng SS, Chan TO, To KW, Ngai J, Tung A, Ko FW, Hui DS. Validation of a portable recording device (ApneaLink) for identifying patients with suspected obstructive sleep apnoea syndrome. Intern Med J. 2009 Nov;39(11):757-62. doi: 10.1111/j.1445-5994.2008.01827.x. Epub 2008 Nov 3.

  PMID: 19220528 RESULT

• Lukachan GA, Chung F, Yadollahi A, Auckley D, Eissa M, Rahman N, McCluskey S, Singh M. Perioperative trends in neck and leg fluid volume in surgical patients: a prospective observational proof-of-concept study. Can J Anaesth. 2023 Feb;70(2):191-201. doi: 10.1007/s12630-022-02362-6. Epub 2022 Nov 30.

  PMID: 36450944 DERIVED

Related Links

• Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr.
• Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4. STOP questionnaire: a tool to screen patients for obstructive sleep apnea.
• Anesthesiology. 2014 Oct;121(4):707-18. doi: 10.1097/ALN.0000000000000407. A matched cohort study of postoperative outcomes in obstructive sleep apnea: could preoperative diagnosis and treatment prevent complications?
• Intern Med J. 2009 Nov;39(11):757-62. doi: 10.1111/j.1445-5994.2008.01827.x. Epub 2008 Nov 3. Validation of a portable recording device (ApneaLink) for identifying patients with suspected obstructive sleep apnoea syndrome.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Mandeep Singh, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 21, 2019
• Study Start: July 22, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: June 23, 2022

Record last verified: 2021-01

Locations

CA (2)