Respiratory InsufficiencyNCT00366353
Sedation Versus No Sedation in a Spontaneous Breathing Trial
A study testing Sedation during SBT and No sedation in people with Respiratory Insufficiency, run by Memorial Medical Center at 1 site in United States.
Trial summary
An important part of how we decide when a patient is ready to have their breathing tube removed is to have a person breathe without any machine breaths while the breathing tube is still in place. We call this a spontaneous breathing trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Sedation during SBT and No sedation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2008
- Phase
- Interventional
- 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
Who may be able to join
- Adult age 18 or older
- Intubation time greater than or equal to 24 hours
- Patient is sedated at the time the MICU writes the order for the SBT. A RASS score of less than -2 will be considered sedated
Who cannot join
- Acute brain injury
- Pregnancy
- Wards of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Medical Center
Johnstown, Pennsylvania, 15905
About this study
Official title: A Randomized Trial Comparing Sedation Versus No Sedation For Patients Undergoing a Spontaneous Breathing Trial.
An important part of how we decide when a patient is ready to have their breathing tube removed is to have a person breathe without any machine breaths while the breathing tube is still in place. We call this a spontaneous breathing trial.
Commonly, while patients have the breathing tube, they are given medications to keep them sedated and comfortable so breathing does not bother them. These medicines are often stopped before the spontaneous breathing trial so they can be more awake for the test.
Read more
There are signs the doctors look for during the spontaneous breathing trial that suggest the patient might not be ready for the breathing trial to come out. Signs like fast breathing, small breaths, a fast heart rate, or looking more anxious than usual may mean that the patient is not ready to come off the ventilator. However, if someone has been given sedation medicines the entire time they have had a breathing tube and are then woken up, they may naturally get very anxious. They may show the same signs as someone who is failing their breathing test, but in their case these signs are only because they are anxious.Doctors may mistake these signs as failing the breathing test and may not pull the breathing tube out even though the patient is really ready for it to come out.
We wish to try and find out if patients do better during their spontaneous breathing trials if they are continued on some sedative medicines to treat anxiety or if they do better if the medicines are stopped before the test.
Read the detailed description
All intubated patients cared for by the Medical Intensive Care Unit (MICU)team during the study period will be evaluated. After 24 hours of mechanical ventilation, patients not meeting any exclusionary criteria will be considered for entrance into our trial. We will attempt to obtain consent as soon as the 24 hour period is fulfilled, even if the patient is not ready for extubation at that point. This is to maximize the success rate for obtaining consent without delaying the SBT when the patient is clinically ready. Given the nature of this protocol, we expect that the informed consent will primarily be obtained from the patient's family member or POA. For all patients who regain competency, they will be re-consented for permission to use their data that has been collected.
Once patients are consented, they will be followed daily by the study investigators. When the order is written by the MICU team for the patient to undergo a SBT, the patient's level of consciousness will be evaluated by the nursing staff using the RASS. If the patient's score is <(-2), they will notify the study investigators. The patient will then be randomized by sealed envelope to one of two study groups. Group 1 will immediately undergo their SBT while still sedated. Group 2 will have their sedation held. Once their RASS score is 0 or higher and they can follow simple commands (holding up two fingers to command), they will be initiated on their SBT.
The standard duration of an SBT by protocol is 2 hours. The duration of SBT may be shorter at the discretion of the ICU attending physician. Additionally, the standard ventilators settings for an SBT is 10 cm of Pressure Support and 5 cm of PEEP (positive and expiratory pressure). This may vary some by the attending's preference though we encourage the use of the standard setting during the study unless there is a clear need to deviate from the protocol. This is to limit the confounding impact that differing levels of Pressure Support may have on the parameters tracked. Patients who are felt to be failing the SBt will be placed back on fill ventilator support at any point directed by the MICU team. Given the lack of objective criteria to define failure of SBT, there are no clear criteria defined and the decision that a patient is failing their SBT will be determined by the attending physician.
Nursing staff will be provided with a documentation form (Data sheet 1) and asked to annotate heart rate, blood pressure, respiratory rate, tidal volume, oxygen saturation, and RASS score at 0, 15, 30, 60 minutes and at the conclusion of the SBT.They will be inserviced on the protocol prior to the start of the study. The study investigators will collect demographic information and record it on Data sheet 2. In addition to the primary endpoint(changes in cardiopulmonary parameters and RASS collected by the nursing staff), secondary endpoints will include outcome of first SBT(pass or fail), time from randomization to extubation, outcome of the first extubation (Data sheet 1). As stated earlier, there are no clearly defined cut-off values for any of the monitored variables that define failure of an SBT.
- Conditions
- Respiratory Insufficiency
- Being tested
- Sedation during SBT, No sedation
- Keywords
- Mechanical Ventilation, Spontaneous Breathing Trial, Sedation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation during SBTOther
No sedationOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Sedation suring a spontaneous breathing trial. Receives: Other: Sedation during SBT |
| 2 | Other | No sedation during spontaneous breathing trial Receives: Other: No sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiopulmonary variables and RASS during the SBT
Measured: 2hrs unless directed by ICU attending physician
Secondary outcomes (1)
Time from randomization to the first SBT
Measured: Time of first SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: Difficulty obtaining enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack L DePriest, Principal investigator, Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366353
- Sponsor's protocol ID
- 05-10
- Status last verified
- May 2015
- First submitted
- 18 Aug 2006
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Sedation Versus No Sedation For Patients Undergoing a Spontaneous Breathing Trial.
- ClinicalTrials.gov ID
- NCT00366353
- Acronym / sponsor ID
- 05-10
- Conditions
- Respiratory Insufficiency
- Keywords
- Mechanical Ventilation, Spontaneous Breathing Trial, Sedation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty obtaining enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Memorial Medical CenterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Aug 2006 (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.
An important part of how we decide when a patient is ready to have their breathing tube removed is to have a person breathe without any machine breaths while the breathing tube is still in place. We call this a spontaneous breathing trial.
Commonly, while patients have the breathing tube, they are given medications to keep them sedated and comfortable so breathing does not bother them. These medicines are often stopped before the spontaneous breathing trial so they can be more awake for the test.
There are signs the doctors look for during the spontaneous breathing trial that suggest the patient might not be ready for the breathing trial to come out. Signs like fast breathing, small breaths, a fast heart rate, or looking more anxious than usual may mean that the patient is not ready to come off the ventilator. However, if someone has been given sedation medicines the entire time they have had a breathing tube and are then woken up, they may naturally get very anxious. They may show the same signs as someone who is failing their breathing test, but in their case these signs are only because they are anxious.Doctors may mistake these signs as failing the breathing test and may not pull the breathing tube out even though the patient is really ready for it to come out.
We wish to try and find out if patients do better during their spontaneous breathing trials if they are continued on some sedative medicines to treat anxiety or if they do better if the medicines are stopped before the test.
Detailed description
All intubated patients cared for by the Medical Intensive Care Unit (MICU)team during the study period will be evaluated. After 24 hours of mechanical ventilation, patients not meeting any exclusionary criteria will be considered for entrance into our trial. We will attempt to obtain consent as soon as the 24 hour period is fulfilled, even if the patient is not ready for extubation at that point. This is to maximize the success rate for obtaining consent without delaying the SBT when the patient is clinically ready. Given the nature of this protocol, we expect that the informed consent will primarily be obtained from the patient's family member or POA. For all patients who regain competency, they will be re-consented for permission to use their data that has been collected.
Once patients are consented, they will be followed daily by the study investigators. When the order is written by the MICU team for the patient to undergo a SBT, the patient's level of consciousness will be evaluated by the nursing staff using the RASS. If the patient's score is <(-2), they will notify the study investigators. The patient will then be randomized by sealed envelope to one of two study groups. Group 1 will immediately undergo their SBT while still sedated. Group 2 will have their sedation held. Once their RASS score is 0 or higher and they can follow simple commands (holding up two fingers to command), they will be initiated on their SBT.
The standard duration of an SBT by protocol is 2 hours. The duration of SBT may be shorter at the discretion of the ICU attending physician. Additionally, the standard ventilators settings for an SBT is 10 cm of Pressure Support and 5 cm of PEEP (positive and expiratory pressure). This may vary some by the attending's preference though we encourage the use of the standard setting during the study unless there is a clear need to deviate from the protocol. This is to limit the confounding impact that differing levels of Pressure Support may have on the parameters tracked. Patients who are felt to be failing the SBt will be placed back on fill ventilator support at any point directed by the MICU team. Given the lack of objective criteria to define failure of SBT, there are no clear criteria defined and the decision that a patient is failing their SBT will be determined by the attending physician.
Nursing staff will be provided with a documentation form (Data sheet 1) and asked to annotate heart rate, blood pressure, respiratory rate, tidal volume, oxygen saturation, and RASS score at 0, 15, 30, 60 minutes and at the conclusion of the SBT.They will be inserviced on the protocol prior to the start of the study. The study investigators will collect demographic information and record it on Data sheet 2. In addition to the primary endpoint(changes in cardiopulmonary parameters and RASS collected by the nursing staff), secondary endpoints will include outcome of first SBT(pass or fail), time from randomization to extubation, outcome of the first extubation (Data sheet 1). As stated earlier, there are no clearly defined cut-off values for any of the monitored variables that define failure of an SBT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Sedation during SBTSedation suring a spontaneous breathing trial. |
| 2 | Other | Other: No sedationNo sedation during spontaneous breathing trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult age 18 or older
- Intubation time greater than or equal to 24 hours
- Patient is sedated at the time the MICU writes the order for the SBT. A RASS score of less than -2 will be considered sedated
Key exclusion criteria (3 listed)
- Acute brain injury
- Pregnancy
- Wards of the state
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 |
|---|---|---|
| Sedation during SBT | Other | 1 |
| No sedation | Other | 2 |
Primary outcome
Changes in cardiopulmonary variables and RASS during the SBT
Time frame: 2hrs unless directed by ICU attending physician
1 secondary outcome
Time from randomization to the first SBT
Time frame: Time of first SBT
Results and safety
The study was stopped early (reason given: Difficulty obtaining enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
Related trials for Respiratory Insufficiency
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Jack L DePriest principal investigator
Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation during SBT and No sedation in people with Respiratory Insufficiency, run by Memorial Medical Center 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: stopped early, as of the sponsor's last update on 18 May 2015. 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?
The study was stopped early (reason given: Difficulty obtaining enrollment). 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?
Changes in cardiopulmonary variables and RASS during the SBT (time frame: 2hrs unless directed by ICU attending physician). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2015.