Critically IllNCT02112604
Predictors of Upper Airway Function and Sleep-disordered Breathing in the Critically Ill
An observational study of Critically Ill and Obstructive Sleep Apnea, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary objective of this study is to examine factors that are related to sleep-disordered breathing and upper airway patency in critically ill patients who have been recently mechanically ventilated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Obstructive Sleep Apnea
- What is being tested?
- Ventilator, Alice PDx and Pulmonary function test
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2016
- 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: Ventilated patients in the surgical intensive unit (SICU)
Who may be able to join
- Patients admitted to the SICU
- Age over 18 years.
- Ventilated patients with an endotracheal tube for at least 24 hours.
Who cannot join
- Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
- Non-cooperative patient, CAM score positive for risk of delirium.
- For women: pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Matthias Eikermann, MD, PhD, 617-643-4408, MEIKERMANN@PARTNERS.ORG
Matthias Eikermann, MD, PhD
About this study
Official title: Determining Predictors of Adequate Upper Airway Function in Ventilated Patients
This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary objective of this study is to examine factors that are related to sleep-disordered breathing and upper airway patency in critically ill patients who have been recently mechanically ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents given in the ICU prior to extubation and during the first night following extubation are associated with sleep-disordered breathing. The secondary hypotheses are that duration of mechanical ventilation, BMI, and muscle strength are associated with sleep-disordered breathing during the night after extubation.
The secondary objective is to evaluate if sleep-disordered breathing in the ICU can be predicted by standard pulmonary function testing in the ICU.
- Conditions
- Critically Ill, Obstructive Sleep Apnea
- Being tested
- Ventilator, Alice PDx, Pulmonary function test, Muscle strength tests, Grip strength measurement
- Keywords
- critically ill, OSA, mechanical ventilation
- Medical subject headings
- Critical Illness, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentilatorDevice
Mechanical ventilator used to replace or assist spontaneous breathing.
Alice PDxDevice
Alice PDx is a polysomnography monitor used to study stages of sleep and detect sleep-disordered breathing. The device monitors PO2, airflow, EEG, EOG and abdominal wall movements to detect sleep apnea.
Pulmonary function testOther
The pulmonary function tests are used to study upper airway patency.
Muscle strength testsOther
MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
Grip strength measurementOther
Grip strength has been shown to be an accurate means of assessing muscle function in the critically ill. Muscle weakness may have an impact on upper airway patency.
Sedatives and muscle relaxants given in the ICUDrug
Patients in the ICU are administered sedatives, anesthetics, opiods, anti-pyschotics and neuromuscular blocking agents as part of routine care. We hypothesize that the use of these drugs is associated with sleep-disordered breathing following extubation. We will collect the drug doses from the patient's chart.
| Study group | Role | What they receive |
|---|---|---|
| Ventilated patients | Patients who have been extubated within 24 hours and have been mechanically ventilated for at least 24 hours. Alice PDx, pulmonary function tests, muscle strength tests, grip strength measurements, ventilator, Sedatives and muscle relaxants given in the ICU Receives: Device: Ventilator; Device: Alice PDx; Other: Pulmonary function test; Other: Muscle strength tests; Other: Grip strength measurement; Drug: Sedatives and muscle relaxants given in the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
The apnea-hypopnea index (AHI) is calculated the night after extubation via a polysomnography device. An AHI ≥ 5 indicates sleep-disordered breathing and obstructive sleep apnea (OSA).
Measured: 1 Night after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Eikermann, Massachusetts General Hospital
- Investigators
- Matthias Eikermann, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112604
- Sponsor's protocol ID
- 2010P001919B
- Status last verified
- Mar 2016
- First submitted
- 10 Apr 2014
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.
PubMed 23584384Timm FP, Zaremba S, Grabitz SD, Farhan HN, Zaremba S, Siliski E, Shin CH, Muse S, Friedrich S, Mojica JE, Kurth T, Ramachandran SK, Eikermann M. Effects of Opioids Given to Facilitate Mechanical Ventilation on Sleep Apnea After Extubation in the Intensive Care Unit. Sleep. 2018 Jan 1;41(1). doi: 10.1093/sleep/zsx191.
PubMed 29182729
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Predictors of Adequate Upper Airway Function in Ventilated Patients
- ClinicalTrials.gov ID
- NCT02112604
- Acronym / sponsor ID
- 2010P001919B
- Conditions
- Critically Ill, Obstructive Sleep Apnea
- Keywords
- critically ill, OSA, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Apr 2014 (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.
This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary objective of this study is to examine factors that are related to sleep-disordered breathing and upper airway patency in critically ill patients who have been recently mechanically ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents given in the ICU prior to extubation and during the first night following extubation are associated with sleep-disordered breathing. The secondary hypotheses are that duration of mechanical ventilation, BMI, and muscle strength are associated with sleep-disordered breathing during the night after extubation.
The secondary objective is to evaluate if sleep-disordered breathing in the ICU can be predicted by standard pulmonary function testing in the ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilated patients | – | Device: Ventilator, Device: Alice PDx, Other: Pulmonary function test, Other: Muscle strength tests, Other: Grip strength measurement, Drug: Sedatives and muscle relaxants given in the ICUPatients who have been extubated within 24 hours and have been mechanically ventilated for at least 24 hours. Alice PDx, pulmonary function tests, muscle strength tests, grip strength measurements, ventilator, Sedatives and muscle relaxants given in the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ventilated patients in the surgical intensive unit (SICU)
Key inclusion criteria (3 listed)
- Patients admitted to the SICU
- Age over 18 years.
- Ventilated patients with an endotracheal tube for at least 24 hours.
Key exclusion criteria (3 listed)
- Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
- Non-cooperative patient, CAM score positive for risk of delirium.
- For women: pregnancy.
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 |
|---|---|---|
| VentilatorMechanical ventilator used to replace or assist spontaneous breathing. | Device | Ventilated patients |
| Alice PDxAlice PDx is a polysomnography monitor used to study stages of sleep and detect sleep-disordered breathing. The device monitors PO2, airflow, EEG, EOG and abdominal wall movements to detect sleep apnea. | Device | Ventilated patients |
| Pulmonary function testThe pulmonary function tests are used to study upper airway patency. | Other | Ventilated patients |
| Muscle strength testsMRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement | Other | Ventilated patients |
| Grip strength measurementGrip strength has been shown to be an accurate means of assessing muscle function in the critically ill. Muscle weakness may have an impact on upper airway patency. | Other | Ventilated patients |
| Sedatives and muscle relaxants given in the ICUPatients in the ICU are administered sedatives, anesthetics, opiods, anti-pyschotics and neuromuscular blocking agents as part of routine care. We hypothesize that the use of these drugs is associated with sleep-disordered breathing following extubation. We will collect the drug doses from the patient's chart. | Drug | Ventilated patients |
Primary outcome
Apnea-hypopnea index (AHI)
Time frame: 1 Night after extubation
The apnea-hypopnea index (AHI) is calculated the night after extubation via a polysomnography device. An AHI ≥ 5 indicates sleep-disordered breathing and obstructive sleep apnea (OSA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Background: PubMed 23584384Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.
- Derived from this study: PubMed 29182729Timm FP, Zaremba S, Grabitz SD, Farhan HN, Zaremba S, Siliski E, Shin CH, Muse S, Friedrich S, Mojica JE, Kurth T, Ramachandran SK, Eikermann M. Effects of Opioids Given to Facilitate Mechanical Ventilation on Sleep Apnea After Extubation in the Intensive Care Unit. Sleep. 2018 Jan 1;41(1). doi: 10.1093/sleep/zsx191.
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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.
Matthias Eikermann, MD, PhD principal investigator
Massachusetts General Hospital
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 Critically Ill and Obstructive Sleep Apnea, run by Massachusetts General Hospital at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Mar 2016. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Eikermann, MD, PhD (617-643-4408, MEIKERMANN@PARTNERS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (AHI) (time frame: 1 Night after extubation). 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 NCT02112604, which also lists 2 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 17 Mar 2016.