Muscle WeaknessNCT01967056
Predictors of Respiratory Failure Following Extubation in the SICU
An observational study of Muscle Weakness and Renal Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Respiratory failure following extubation causes significant morbidity and increases mortality in teh surgical intensive care unit (SICU). However the causes of respiratory failure following extubation remain poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Renal Failure, Respiratory Comorbidities
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2014
- 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: The population of patients used for this study will be those admitted to the Surgical Intensive Care Unit
Who may be able to join
- Adults (18 years of age or greater)
- Patients who have been extubated following mechanical ventilation in the surgical ICU
Who cannot join
- Preexisting end-stage renal disease
- Neurological disorder associated with severe muscle weakness
- Goals of care focused on comfort
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ulrich Schmidt, MD, 617-643-4408, uschmidt@partners.org
About this study
Official title: Predictors of Respiratory Failure Following Extubation in Teh Surgical Intensive Care Unit (SICU)
Respiratory failure following extubation causes significant morbidity and increases mortality in teh surgical intensive care unit (SICU). However the causes of respiratory failure following extubation remain poorly understood. The investigators hypothesize that extubation failure can be predicted based on preoperative risk factors as well as ICU acquired morbidities including muscle weakness and renal failure.
Read the detailed description
Both extubation delay and extubation failure are related to adverse outcomes. A spontaneous breathing trial is therefore recommended to predict extubation readiness. However, depending on the disease entity and local culture, a range of 10-20 per cent incidence of extubation failure has been described from tertiary care hospitals. The aim of this trial is to identify additional variables in surgical patients that can be used to support a clinician's decision on whether or not to extubate a patient's trachea.
Te investigators have recently developed and validated the SPORC (Brueckmann, 2013), a score that predicts the risk of extubation failure following surgery based on patients comorbidities and the acuity of the disease leading to surgery, and the investigators hypothesize that the SPORC will also predict extubation failure in the surgical ICU.
In addition, it is likely that ICU acquired morbidity also predicts extubation failure. In fact, the investigators have recently shown that muscle weakness is a predictor of aspiration (Mirzakhani, 2013), and the investigators speculated that muscle weakness may also respiratory failure after extubation.
Finally, it has been suggested that the increased mortality seen in patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) versus end stage renal disease (ESRD) patients requiring CRRT can be attributed to an increased need for mechanical ventilation. (Walcher, 2011). Therefore, the investigators also hypothesize that acute kidney injury increases the vulnerability of patients to postextubation respiratory failure.
- Conditions
- Muscle Weakness, Renal Failure, Respiratory Comorbidities
- Keywords
- Muscle strength, respiratory failure, extubation failure, intensive care unit, outcome prediction
- Medical subject headings
- Muscle Weakness, Renal Insufficiency, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Failure
The investigators defined respiratory failure as a composite endpoint including reintubation within 72 hours, use of non-invasive ventilation for treatment of extubation failure, and tracheostomy during hospitalization (expected time of 30 days post extubation)
Measured: 30 days
Secondary outcomes (5)
Reintubation within 72 hours
The investigators will follow patients and observe whether they require reintubation within 72 h
Measured: 72 hours
Non-invasive ventilation for treatment of extubation failure
The investigators will follow patients and observe whether they require non-invasive ventilation for extubation failure
Measured: 72 hours
Tracheostomy
Measured: Patients will be followed for 30 days of hospitalization
SICU length of stay
Measured: 180 days
Hospital length of stay
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Schmidt, Massachusetts General Hospital
- Investigators
- Ulrich Schmidt, MD, Principal investigator, The Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967056
- Sponsor's protocol ID
- 2012P001783
- Status last verified
- Oct 2013
- First submitted
- 16 Oct 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Brueckmann B, Villa-Uribe JL, Bateman BT, Grosse-Sundrup M, Hess DR, Schlett CL, Eikermann M. Development and validation of a score for prediction of postoperative respiratory complications. Anesthesiology. 2013 Jun;118(6):1276-85. doi: 10.1097/ALN.0b013e318293065c.
PubMed 23571640Mirzakhani 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 23584384Walcher A, Faubel S, Keniston A, Dennen P. In critically ill patients requiring CRRT, AKI is associated with increased respiratory failure and death versus ESRD. Ren Fail. 2011;33(10):935-42. doi: 10.3109/0886022X.2011.615964. Epub 2011 Sep 13.
PubMed 21910664Bittner EA, Schmidt UH. Tracheal reintubation: caused by "too much of a good thing"? Respir Care. 2012 Oct;57(10):1687-91. doi: 10.4187/respcare.02082. No abstract available.
PubMed 23013905Fuchs G, Thevathasan T, Chretien YR, Mario J, Piriyapatsom A, Schmidt U, Eikermann M, Fintelmann FJ. Lumbar skeletal muscle index derived from routine computed tomography exams predict adverse post-extubation outcomes in critically ill patients. J Crit Care. 2018 Apr;44:117-123. doi: 10.1016/j.jcrc.2017.10.033. Epub 2017 Oct 23.
PubMed 29096229Piriyapatsom A, Williams EC, Waak K, Ladha KS, Eikermann M, Schmidt UH. Prospective Observational Study of Predictors of Re-Intubation Following Extubation in the Surgical ICU. Respir Care. 2016 Mar;61(3):306-15. doi: 10.4187/respcare.04269. Epub 2015 Nov 10.
PubMed 26556899
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Respiratory Failure Following Extubation in Teh Surgical Intensive Care Unit (SICU)
- ClinicalTrials.gov ID
- NCT01967056
- Acronym / sponsor ID
- 2012P001783
- Conditions
- Muscle Weakness, Renal Failure, Respiratory Comorbidities
- Keywords
- Muscle strength, respiratory failure, extubation failure, intensive care unit, outcome prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 22 Oct 2013 (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.
Respiratory failure following extubation causes significant morbidity and increases mortality in teh surgical intensive care unit (SICU). However the causes of respiratory failure following extubation remain poorly understood. The investigators hypothesize that extubation failure can be predicted based on preoperative risk factors as well as ICU acquired morbidities including muscle weakness and renal failure.
Detailed description
Both extubation delay and extubation failure are related to adverse outcomes. A spontaneous breathing trial is therefore recommended to predict extubation readiness. However, depending on the disease entity and local culture, a range of 10-20 per cent incidence of extubation failure has been described from tertiary care hospitals. The aim of this trial is to identify additional variables in surgical patients that can be used to support a clinician's decision on whether or not to extubate a patient's trachea.
Te investigators have recently developed and validated the SPORC (Brueckmann, 2013), a score that predicts the risk of extubation failure following surgery based on patients comorbidities and the acuity of the disease leading to surgery, and the investigators hypothesize that the SPORC will also predict extubation failure in the surgical ICU.
In addition, it is likely that ICU acquired morbidity also predicts extubation failure. In fact, the investigators have recently shown that muscle weakness is a predictor of aspiration (Mirzakhani, 2013), and the investigators speculated that muscle weakness may also respiratory failure after extubation.
Finally, it has been suggested that the increased mortality seen in patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) versus end stage renal disease (ESRD) patients requiring CRRT can be attributed to an increased need for mechanical ventilation. (Walcher, 2011). Therefore, the investigators also hypothesize that acute kidney injury increases the vulnerability of patients to postextubation respiratory failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of patients used for this study will be those admitted to the Surgical Intensive Care Unit
Key inclusion criteria (2 listed)
- Adults (18 years of age or greater)
- Patients who have been extubated following mechanical ventilation in the surgical ICU
Key exclusion criteria (3 listed)
- Preexisting end-stage renal disease
- Neurological disorder associated with severe muscle weakness
- Goals of care focused on comfort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Failure
Time frame: 30 days
The investigators defined respiratory failure as a composite endpoint including reintubation within 72 hours, use of non-invasive ventilation for treatment of extubation failure, and tracheostomy during hospitalization (expected time of 30 days post extubation)
5 secondary outcomes
Reintubation within 72 hours
Time frame: 72 hours
Non-invasive ventilation for treatment of extubation failure
Time frame: 72 hours
Tracheostomy
Time frame: Patients will be followed for 30 days of hospitalization
SICU length of stay
Time frame: 180 days
Hospital length of stay
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
- Background: PubMed 23571640Brueckmann B, Villa-Uribe JL, Bateman BT, Grosse-Sundrup M, Hess DR, Schlett CL, Eikermann M. Development and validation of a score for prediction of postoperative respiratory complications. Anesthesiology. 2013 Jun;118(6):1276-85. doi: 10.1097/ALN.0b013e318293065c.
- 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.
- Background: PubMed 21910664Walcher A, Faubel S, Keniston A, Dennen P. In critically ill patients requiring CRRT, AKI is associated with increased respiratory failure and death versus ESRD. Ren Fail. 2011;33(10):935-42. doi: 10.3109/0886022X.2011.615964. Epub 2011 Sep 13.
- Background: PubMed 23013905Bittner EA, Schmidt UH. Tracheal reintubation: caused by "too much of a good thing"? Respir Care. 2012 Oct;57(10):1687-91. doi: 10.4187/respcare.02082. No abstract available.
- Derived from this study: PubMed 29096229Fuchs G, Thevathasan T, Chretien YR, Mario J, Piriyapatsom A, Schmidt U, Eikermann M, Fintelmann FJ. Lumbar skeletal muscle index derived from routine computed tomography exams predict adverse post-extubation outcomes in critically ill patients. J Crit Care. 2018 Apr;44:117-123. doi: 10.1016/j.jcrc.2017.10.033. Epub 2017 Oct 23.
- Derived from this study: PubMed 26556899Piriyapatsom A, Williams EC, Waak K, Ladha KS, Eikermann M, Schmidt UH. Prospective Observational Study of Predictors of Re-Intubation Following Extubation in the Surgical ICU. Respir Care. 2016 Mar;61(3):306-15. doi: 10.4187/respcare.04269. Epub 2015 Nov 10.
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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.
Ulrich Schmidt, MD principal investigator
The 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 Muscle Weakness and Renal Failure, 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 2 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 22 Oct 2013. 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 Ulrich Schmidt, M.D (617-643-4408, uschmidt@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Failure (time frame: 30 days). 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 NCT01967056, which also lists 6 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 22 Oct 2013.