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

Obstructive Sleep Apnea Clinical Trial

Official title:

The Variability and Impact of Segmental Neck and Leg Fluid Volume Shifts on Upper Airway Collapse and Obstructive Sleep Apnea (OSA) Severity in Surgical Patients With OSA

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03850041
• Other study ID #: 18-5747
• Status: Terminated
• Start date: July 22, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: January 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study investigators hypothesize that in obstructive sleep apnea (OSA) patients undergoing elective non-cardiac surgery, preferential increase in neck fluid volume following intravenous administration during general anesthesia results in worsening apnea-hypopnea (AHI) and postoperative respiratory complications.This is a two-center study where the study population will be drawn from patients visiting preoperative clinic at University Health Network Hospitals, Toronto Western Hospital, and Toronto General Hospital.

Objectives of the study

• Measure the change in the leg, neck and total fluid volume from preoperative baseline, postoperative care unit (PACU), first postoperative night (Night 1) and the morning after surgery (Day 2)

• Assess the impact of the change in neck fluid volume on respiratory mechanics and postoperative apnea-hypopnea index (AHI) the first postoperative night (Night 1) In this study, the investigators will perform serial measurements of segmental and total body water shifts occurring after surgery, at various time-points on the night and the morning after surgery. The investigators 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 this study will be made more robust by use of well-validated methods such as Bioelectrical Impedance Analysis (BIA) for fluid measurements, portable Apnea Link for OSA severity and tremflow airway oscillometry for the airway resistance.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients (>18 yrs)

2. 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)

3. ASA physical status I - IV

4. Patients undergoing elective non-cardiac surgery under general anesthesia;

5. Patients requiring overnight admission.

Exclusion Criteria:

1. Patients compliant on OSA treatment such as continuous positive airway pressure therapy or an oral appliance

2. Vascular surgery on the lower limbs, or metal implants in lower limbs

3. Pregnant or lactating patients

4. Cardiac, intra-cranial, or neck procedures.

5. Inability to communicate: with health care providers or the research personnel, inability to perform breathing maneuvers such as spirometry, or inability to follow instructions.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Lung Association

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

Durán 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. — View Citation

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: 10.10 — View Citation

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.1445-5994.2008.0182 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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: No OSA( AHI: 0-5 events/hour),; Mild OSA(AHI: 6 to 15 events/hour),; Moderate OSA (AHI : 16-30 events/hour) and; Severe OSA (AHI: >30 events/hour),	24 hours
Secondary	Neck Circumference on Postoperative Night 1	Neck circumference (in cm) will be assessed with a measuring tape and reported for correlation with other data	24 hours

External 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.