Obstructive Sleep ApneaNCT02666781
Postoperative Rostral Fluid Shift and Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- ApneaLink Plus, BIA Device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2016to 18 Jun 2018
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Contribution of Rostral Shift of Fluid to Postoperative Worsening of Obstructive Sleep Apnea Severity in Surgical Patients - A Prospective Cohort Study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- ApneaLink Plus, BIA Device
- Keywords
- OSA, Surgery, Postoperative, Rostral Fluid Shift
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApneaLink Plus, BIA DeviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Group | Postoperative surgical Patients with or without Obstructive Sleep Apnea Receives: Other: ApneaLink Plus, BIA Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg, neck and total body fluid volume on postoperative nights 1 and 2
Compartmental Fluids will be measured using an bioelectrical impedance device (BIA)
Measured: 48 hours
Secondary outcomes (2)
Neck Circumference on Postoperative Nights 1 and 2
Neck circumference (in cm) will be assessed with a measuring tape and reported for correlation with other data
Measured: 48 hours
Apnea Hypopnea Index (AHI) on Postoperative Night 1
AHI will be measured as an indicator for the severity of Obstructive Sleep Apnea using an ApneaLink plus device.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start22 Apr 2016
- Primary completion16 Jun 2017
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Anesthesia and Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Mandeep Singh, MD,FRCPC, Principal investigator, Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666781
- Sponsor's protocol ID
- 15-9507
- Status last verified
- May 2023
- First submitted
- 11 Jan 2016
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 11254524Mutter 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 25247853Chung 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 18431116Ng 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 19220528Lukachan 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Rostral Shift of Fluid to Postoperative Worsening of Obstructive Sleep Apnea Severity in Surgical Patients - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02666781
- Acronym / sponsor ID
- 15-9507
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Surgery, Postoperative, Rostral Fluid Shift
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Society of Anesthesia and Sleep Medicine
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Group | – | Other: ApneaLink Plus, BIA DevicePostoperative surgical Patients with or without Obstructive Sleep Apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApneaLink Plus, BIA DeviceThe 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. | Other | Pilot Group |
Primary outcome
Leg, neck and total body fluid volume on postoperative nights 1 and 2
Time frame: 48 hours
Compartmental Fluids will be measured using an bioelectrical impedance device (BIA)
2 secondary outcomes
Neck Circumference on Postoperative Nights 1 and 2
Time frame: 48 hours
Apnea Hypopnea Index (AHI) on Postoperative Night 1
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 11254524Duran 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.
- Background: PubMed 25247853Mutter 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.
- Background: PubMed 18431116Chung 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.
- Background: PubMed 19220528Ng 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.
- Derived from this study: PubMed 36450944Lukachan 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.
- Official Website for "STOP-Bang" Screening Questionnaire for Diagnosis of Obstructive Sleep ApneaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandeep Singh, MD,FRCPC principal investigator
Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Health Network, Toronto at 1 site 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Leg, neck and total body fluid volume on postoperative nights 1 and 2 (time frame: 48 hours). 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 NCT02666781, 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 18 May 2023.