Postoperative Rostral Fluid Shift and Obstructive Sleep Apnea

NCT02666781 | Completed

• 1 other identifier: 15-9507
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

OSA, Surgery, Postoperative, Rostral Fluid Shift

Outcome Measures

Primary Outcomes (1)

• Leg, neck and total body fluid volume on postoperative nights 1 and 2

  Compartmental Fluids will be measured using an bioelectrical impedance device (BIA)

  48 hours

Secondary Outcomes (2)

• Neck Circumference on Postoperative Nights 1 and 2

  48 hours

• Apnea Hypopnea Index (AHI) on Postoperative Night 1

  24 hours

Study Arms (1)

Pilot Group

Postoperative surgical Patients with or without Obstructive Sleep Apnea

Other: ApneaLink Plus, BIA Device

Interventions

ApneaLink Plus, BIA Device OTHER

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.

Pilot Group

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:

• American Society of Anesthesiologists (ASA) physical status I to IV
• 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 not qualify if:

• Patients undergoing cardiac, intracranial surgery, procedures involving the neck such as cervical spine surgery, or carotid endarterectomy.
• Patients requiring epidural or spinal anesthesia for their surgery, as neuraxial blockade may impact fluid shifts from legs to neck and may confound our results.
• Prior history of vascular surgery in the lower limbs such as varicose vein surgery, vascular by-pass surgery or evidence of venous efficiency.
• Fluid overload states such as history of congestive heart failure, or renal failure will be excluded.
• Patients with metal implants in lower limbs or spine, due to possible interference with the leg impedance signals.
• Patients requiring urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guidelines e.g. unstable ischemic heart disease, recent cerebrovascular disease, congestive heart failure, obstructive/restrictive lung disease, pulmonary hypertension, hypercapnia respiratory failure.
• Pregnant or lactating patients, as the physiological mechanisms governing postoperative fluid shifts are different in this patient population.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Society of Anesthesia and Sleep Medicine: collaborator

Study Sites (1)

Toronto Western Hospital- UHN

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

• 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 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 BACKGROUND

• 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 BACKGROUND

• 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

• Official Website for "STOP-Bang" Screening Questionnaire for Diagnosis of Obstructive Sleep Apnea

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

  Department of Anesthesia, Toronto Western Hospital- UHN, University of 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 11, 2016
• First Posted: January 28, 2016
• Study Start: April 22, 2016
• Primary Completion: June 16, 2017
• Study Completion: June 18, 2018
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

CA (1)