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Obstructive Sleep ApneaNCT03850041

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

An observational study of Obstructive Sleep Apnea, run by University Health Network, Toronto at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea
How many people
50 participants
Where
2 sitesCanada
Study dates
22 Jul 2019to 14 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

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

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.

Read the detailed 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.
Medical subject headings
Sleep Apnea, Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours

  2. 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),

    Measured: 24 hours

Secondary outcomes (1)

  1. Neck Circumference on Postoperative Night 1

    Neck circumference (in cm) will be assessed with a measuring tape and reported for correlation with other data

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2019
  2. Study start22 Jul 2019
  3. Primary completion14 Dec 2020
  4. Study completion14 Dec 2020

Why it stopped: lapse of renewal

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850041
Sponsor's protocol ID
18-5747
Status last verified
Jan 2021
First submitted
30 Jan 2019
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 11254524

  • 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.

    PubMed 18431116

  • 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.

    PubMed 25247853

  • 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.

    PubMed 19220528

  • 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.

    PubMed 36450944

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea, run by University Health Network, Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: lapse of renewal). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck, leg and total body water volumes preoperatively and on postoperative night 1 and the morning after surgery (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850041, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.

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