Respiratory InsufficiencySLEEWENCT02464735
Effect of Sleep Disruption on the Outcome of Weaning From Mechanical Ventilation
An observational study of Respiratory Insufficiency, run by Unity Health Toronto at 3 sites in Canada.
Trial summary
Mechanically ventilated patients in the Intensive Care Unit (ICU) are highly susceptible to sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold standard method for evaluating sleep… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Polysomnography
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jan 2016to Sep 2017
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mechanically ventilated Intensive Care Unit patients who have a spontaneous breathing trial planned for the next day.
Who may be able to join
- Age > 16 years
- Intubated and mechanically ventilated
- A spontaneous breathing trial (SBT) is planned for the next day; patients can be enrolled if they have already had previous SBTs
Who cannot join
- Presence of recent major central nervous system disease impairing consciousness with Glasgow Coma Scale ≤ 8T
- Patients with a sleep breathing disorder when it is predominantly central sleep apnea; patients with predominantly obstructive sleep apnea can be included
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Mechanically ventilated patients in the Intensive Care Unit (ICU) are highly susceptible to sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold standard method for evaluating sleep quality and quantity). Discontinuation of mechanical ventilation should be considered as soon as possible when a patient's condition starts to improve. A patient's ability to be weaned from the mechanical ventilator can be assessed using two step approaches including a Rapid Shallow Breathing Index (RSBI) calculation then a spontaneous breathing trial (SBT) to determine the likelihood of success or failure before considering endotracheal extubation. The rate of weaning failure from the first SBT attempt has been reported to be 35-55%. The reason for weaning failure may be complex and multifactorial. An association between sleep disruption and weaning outcome has never been studied. The goal of this study is to look for an association between poor sleep quality and failure of a weaning attempt.
This study is an observational, physiological study investigating sleep quality and quantity in patients who will be weaned by recording standard PSG (from 17:00 to 08:00) at night before a weaning attempt. Sleep characteristics of patients failing or passing the weaning attempt will be compared. In addition, we will compare sleep patterns before and after endotracheal extubation.
Read the detailed description
This clinical physiological study will take place over a period of 2-14 days, depending on the participant.
Assessment of the readiness to wean using RSBI calculation and an SBT are standard practice in the ICU, and the decision to perform one is made by the ICU team. They are usually performed in the morning between 08:00 and 10:00. The RSBI calculation will be performed by disconnecting the patient from the ventilator for 2-3 minutes and then measuring the breathing frequency and average tidal volume for 1 minute. A value of the RSBI index < 100-105 breaths/min×L predicts a possible successful SBT. The SBT will be performed using flow-by technique (Pressure Support (PS)/Continuous Positive Airway Pressure (CPAP) 0/0 cmH2O) for 30 to 120 minutes and at a Fraction of Inspired Oxygen (FiO2) below 0.5 when the RSBI index < 100-105 breaths/min×L. A T-piece trial gives the most reliable assessment of weaning capability, but it is often reserved for the most challenging patients. Using flow-by (PS/CPAP 0/0 cmH2O) will give a similar indication of weaning capability in comparison to T-piece, but will allow the Respiratory Therapists to keep the same equipment and to monitor tidal volume and minute ventilation throughout the test. During the SBT, respiratory and hemodynamic parameters will be continuously monitored. Determining the success or failure of the SBT will be performed by the clinical team. For patients who pass the SBT, the decision for extubation is made by the ICU clinical team independently from this study. For the purpose of the study, a daily screening will be performed each afternoon by the Respiratory Therapist to identify patients who will have a RSBI calculation and an SBT the following day.
On the night prior to the planned weaning assessment, sleep architecture will be recorded using standard PSG (electroencephalography, right and left electrooculography, submental electromyography and electrocardiography) from 17:00 to 8:00. Pulse oximetry (SpO2) and end-tidal carbon dioxide (EtCO2) or transcutaneous partial pressure of carbon dioxide (PtcCO2) will be recorded continuously during the PSG.
For patients who pass the RSBI index and SBT and are extubated successfully, PSG recording will be repeated that night. If the patient passes the SBT but is not extubated, we will wait for a new extubation attempt within the next 48 hours. If extubation is performed within the next 48 hours, PSG recording will be repeated the night of extubation. If extubation is further delayed, no PSG will be performed.
For patients who fail the 1st RSBI or fail the 1st SBT, PSG recording will be repeated the night before the next weaning attempt and the night of extubation if it happens within a maximum of two weeks from the 1st SBT.
Assessment of delirium will be performed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily (at 08:00 and 18:00) from day 0 until extubation.
- Conditions
- Respiratory Insufficiency
- Being tested
- Polysomnography
- Keywords
- Sleep disruption, Spontaneous breathing trial, Weaning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sleep quality between patients who pass weaning and patients who fail a weaning assessment
Measured: 15 hours
Comparison of sleep quality (sleep efficiency and fragmentation) the night before a patient fails weaning and the night after they eventually pass weaning
Measured: 30 hours
Secondary outcomes (5)
Comparison between patients who pass and patients who fail weaning in terms of % of rapid eye movement sleep, sleep quantity (or efficiency), slow wave sleep and circadian sleep ratio, % of "pathological/atypical" sleep patterns, and sleep continuity
Measured: 15 hours
Comparison of sleep architecture (total sleep time, % of NREM and REM sleep) the night before weaning and the night of extubation
Measured: 30 hours
Incidence of delirium amongst all patient groups, regardless of the outcome of weaning
Assessed using the Confusion Assessment Method for the Intensive Care Unit twice daily (at 08:00 and 18:00) each day until extubation.
Measured: Up to 14 days
Analysis of the validity of the odds ratio product (ORP) technique for classification of sleep depth in comparison to standard PSG criteria by American Academy of Sleep Medicine (AASM).
Measured: Up to 14 days
Correlation between sleep disruption and delirium.
Assessed using the Confusion Assessment Method for the Intensive Care Unit twice daily (at 08:00 and 18:00) each day until extubation.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start1 Jan 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Unity Health 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464735
- Sponsor's protocol ID
- REB# 15-142
- Acronym
- SLEEWE
- Status last verified
- Apr 2018
- First submitted
- 28 May 2015
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Drouot X, Cabello B, d'Ortho MP, Brochard L. Sleep in the intensive care unit. Sleep Med Rev. 2008 Oct;12(5):391-403. doi: 10.1016/j.smrv.2007.11.004. Epub 2008 May 23.
PubMed 18502155Roche Campo F, Drouot X, Thille AW, Galia F, Cabello B, d'Ortho MP, Brochard L. Poor sleep quality is associated with late noninvasive ventilation failure in patients with acute hypercapnic respiratory failure. Crit Care Med. 2010 Feb;38(2):477-85. doi: 10.1097/CCM.0b013e3181bc8243.
PubMed 19789439Tobin MJ. Extubation and the myth of "minimal ventilator settings". Am J Respir Crit Care Med. 2012 Feb 15;185(4):349-50. doi: 10.1164/rccm.201201-0050ED. No abstract available.
PubMed 22336673Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Disruption on the Outcome of Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02464735
- Acronym / sponsor ID
- SLEEWE / REB# 15-142
- Conditions
- Respiratory Insufficiency
- Keywords
- Sleep disruption, Spontaneous breathing trial, Weaning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 8 Jun 2015 (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.
Mechanically ventilated patients in the Intensive Care Unit (ICU) are highly susceptible to sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold standard method for evaluating sleep quality and quantity). Discontinuation of mechanical ventilation should be considered as soon as possible when a patient's condition starts to improve. A patient's ability to be weaned from the mechanical ventilator can be assessed using two step approaches including a Rapid Shallow Breathing Index (RSBI) calculation then a spontaneous breathing trial (SBT) to determine the likelihood of success or failure before considering endotracheal extubation. The rate of weaning failure from the first SBT attempt has been reported to be 35-55%. The reason for weaning failure may be complex and multifactorial. An association between sleep disruption and weaning outcome has never been studied. The goal of this study is to look for an association between poor sleep quality and failure of a weaning attempt.
This study is an observational, physiological study investigating sleep quality and quantity in patients who will be weaned by recording standard PSG (from 17:00 to 08:00) at night before a weaning attempt. Sleep characteristics of patients failing or passing the weaning attempt will be compared. In addition, we will compare sleep patterns before and after endotracheal extubation.
Detailed description
This clinical physiological study will take place over a period of 2-14 days, depending on the participant.
Assessment of the readiness to wean using RSBI calculation and an SBT are standard practice in the ICU, and the decision to perform one is made by the ICU team. They are usually performed in the morning between 08:00 and 10:00. The RSBI calculation will be performed by disconnecting the patient from the ventilator for 2-3 minutes and then measuring the breathing frequency and average tidal volume for 1 minute. A value of the RSBI index < 100-105 breaths/min×L predicts a possible successful SBT. The SBT will be performed using flow-by technique (Pressure Support (PS)/Continuous Positive Airway Pressure (CPAP) 0/0 cmH2O) for 30 to 120 minutes and at a Fraction of Inspired Oxygen (FiO2) below 0.5 when the RSBI index < 100-105 breaths/min×L. A T-piece trial gives the most reliable assessment of weaning capability, but it is often reserved for the most challenging patients. Using flow-by (PS/CPAP 0/0 cmH2O) will give a similar indication of weaning capability in comparison to T-piece, but will allow the Respiratory Therapists to keep the same equipment and to monitor tidal volume and minute ventilation throughout the test. During the SBT, respiratory and hemodynamic parameters will be continuously monitored. Determining the success or failure of the SBT will be performed by the clinical team. For patients who pass the SBT, the decision for extubation is made by the ICU clinical team independently from this study. For the purpose of the study, a daily screening will be performed each afternoon by the Respiratory Therapist to identify patients who will have a RSBI calculation and an SBT the following day.
On the night prior to the planned weaning assessment, sleep architecture will be recorded using standard PSG (electroencephalography, right and left electrooculography, submental electromyography and electrocardiography) from 17:00 to 8:00. Pulse oximetry (SpO2) and end-tidal carbon dioxide (EtCO2) or transcutaneous partial pressure of carbon dioxide (PtcCO2) will be recorded continuously during the PSG.
For patients who pass the RSBI index and SBT and are extubated successfully, PSG recording will be repeated that night. If the patient passes the SBT but is not extubated, we will wait for a new extubation attempt within the next 48 hours. If extubation is performed within the next 48 hours, PSG recording will be repeated the night of extubation. If extubation is further delayed, no PSG will be performed.
For patients who fail the 1st RSBI or fail the 1st SBT, PSG recording will be repeated the night before the next weaning attempt and the night of extubation if it happens within a maximum of two weeks from the 1st SBT.
Assessment of delirium will be performed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily (at 08:00 and 18:00) from day 0 until extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mechanically ventilated Intensive Care Unit patients who have a spontaneous breathing trial planned for the next day.
Key inclusion criteria (3 listed)
- Age > 16 years
- Intubated and mechanically ventilated
- A spontaneous breathing trial (SBT) is planned for the next day; patients can be enrolled if they have already had previous SBTs
Key exclusion criteria (2 listed)
- Presence of recent major central nervous system disease impairing consciousness with Glasgow Coma Scale ≤ 8T
- Patients with a sleep breathing disorder when it is predominantly central sleep apnea; patients with predominantly obstructive sleep apnea can be included
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 |
|---|---|---|
| Polysomnography | Device | – |
Primary outcome
Comparison of sleep quality between patients who pass weaning and patients who fail a weaning assessment
Time frame: 15 hours
Comparison of sleep quality (sleep efficiency and fragmentation) the night before a patient fails weaning and the night after they eventually pass weaning
Time frame: 30 hours
5 secondary outcomes
Comparison between patients who pass and patients who fail weaning in terms of % of rapid eye movement sleep, sleep quantity (or efficiency), slow wave sleep and circadian sleep ratio, % of "pathological/atypical" sleep patterns, and sleep continuity
Time frame: 15 hours
Comparison of sleep architecture (total sleep time, % of NREM and REM sleep) the night before weaning and the night of extubation
Time frame: 30 hours
Incidence of delirium amongst all patient groups, regardless of the outcome of weaning
Time frame: Up to 14 days
Analysis of the validity of the odds ratio product (ORP) technique for classification of sleep depth in comparison to standard PSG criteria by American Academy of Sleep Medicine (AASM).
Time frame: Up to 14 days
Correlation between sleep disruption and delirium.
Time frame: Up to 14 days
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 12 Apr 2018.
- Background: PubMed 18502155Drouot X, Cabello B, d'Ortho MP, Brochard L. Sleep in the intensive care unit. Sleep Med Rev. 2008 Oct;12(5):391-403. doi: 10.1016/j.smrv.2007.11.004. Epub 2008 May 23.
- Background: PubMed 19789439Roche Campo F, Drouot X, Thille AW, Galia F, Cabello B, d'Ortho MP, Brochard L. Poor sleep quality is associated with late noninvasive ventilation failure in patients with acute hypercapnic respiratory failure. Crit Care Med. 2010 Feb;38(2):477-85. doi: 10.1097/CCM.0b013e3181bc8243.
- Background: PubMed 22336673Tobin MJ. Extubation and the myth of "minimal ventilator settings". Am J Respir Crit Care Med. 2012 Feb 15;185(4):349-50. doi: 10.1164/rccm.201201-0050ED. No abstract available.
- Background: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency, run by Unity Health Toronto at 3 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 3 inclusion and 2 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 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Comparison of sleep quality between patients who pass weaning and patients who fail a weaning assessment (time frame: 15 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 NCT02464735, which also lists 4 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 12 Apr 2018.