- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02666781
Postoperative Rostral Fluid Shift and Obstructive Sleep Apnea
The Contribution of Rostral Shift of Fluid to Postoperative Worsening of Obstructive Sleep Apnea Severity in Surgical Patients - A Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder, associated with increased morbidity and mortality. It is an independent risk-factor for post-operative cardio-respiratory complications and increased perioperative utilization of health care resources. In non-surgical patients, rostral fluid shift from the lower limbs to the neck has been identified as a pathophysiologic mechanism to explain OSA severity based on gender, increasing age, and in fluid-overload states. In this novel study, our objective is to examine the contribution of fluid shift from the lower limbs to the neck thereby leading to worsening of sleep apnea following surgery.
Objectives of the study
- Measure the change in the leg, neck and total fluid volume from preoperative baseline to the second postoperative day.
- Assess the impact of the change in neck fluid volume on neck circumference and postoperative AHI.
Similar to the patients with heart failure, renal failure and older men, we hypothesize the rostral shift of fluid from the lower limbs to the neck occurs in the postoperative period contributing to the postoperative worsening of OSA. In this study, we will perform serial measurements of segmental and total body water shifts occurring after surgery, at various time-points over two postoperative days. We will monitor indices such as the Apnea Hypopnea index (AHI) and oxygen desaturation index (ODI) to examine changes in the severity of OSA. Internal validity of our study will be made more robust by use of well-validated methods such as BIA for fluid measurements and portable PSG for OSA severity.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital- UHN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pilot Group
Postoperative surgical Patients with or without Obstructive Sleep Apnea
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leg, neck and total body fluid volume on postoperative nights 1 and 2
Time Frame: 48 hours
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Compartmental Fluids will be measured using an bioelectrical impedance device (BIA)
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48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Circumference on Postoperative Nights 1 and 2
Time Frame: 48 hours
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Neck circumference (in cm) will be assessed with a measuring tape and reported for correlation with other data
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48 hours
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Apnea Hypopnea Index (AHI) on Postoperative Night 1
Time Frame: 24 hours
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AHI will be measured as an indicator for the severity of Obstructive Sleep Apnea using an ApneaLink plus device.
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24 hours
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mandeep Singh, MD,FRCPC, Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-9507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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