Acute Respiratory FailureBOUGIENCT03928925
Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)
A study testing Bougie and Endotracheal Tube with Stylet in people with Acute Respiratory Failure, run by Vanderbilt University Medical Center at 11 sites in United States.
Trial summary
Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt during tracheal intubations outside of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Bougie and Endotracheal Tube with Stylet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,106 participants
- Where
- 11 sitesUnited States
- Study dates
- 29 Apr 2019to 13 Mar 2021
- 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
- Patient is located in a participating unit of an adult hospital
- Planned procedure is tracheal intubation with sedative administration (or tracheal intubation without sedative administration during cardiac arrest)
- Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
- Planned laryngoscopy device is a non-hyperangulated laryngoscope blade
Who cannot join
- Patient is pregnant
- Patient is a prisoner
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an approach to intubation other than use of a bougie or use of an endotracheal tube with stylet would be best for the care of the patient
- Operator feels use of a bougie is required or contraindicated for the care of the patient
- Operator feels use of an endotracheal tube with stylet is required or contraindicated for the care of the patient
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Colorado
Denver, Colorado, 80045
Denver Health and Hospital Authority
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 27710
University of Iowa Hospital
Iowa City, Iowa, 52242
Wake Forest Baptist Health
Lexington, North Carolina, 27292
Vanderbilt University Medical Center
Nashville, Tennessee, 37209
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112
Ochsner Medical Center | Ochsner Health System
New Orleans, Louisiana, 70112
Harborview Medical Center, University of Washington
Seattle, Washington, 98104
Lincoln Medical Center
The Bronx, New York, 10451
About this study
Official title: Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE): a Randomized, Multi-center Trial
Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt during tracheal intubations outside of the operating room is less than 90%. The bougie, a thin semi-rigid tube that can be placed into the trachea, allowing a Seldinger-like technique of intubating a patient's airway, has been traditionally reserved for difficult or failed airways. However, a recent single center trial of adult patients intubated in an emergency department demonstrated that use of the bougie on the first attempt improved intubation success, compared to use of a traditional stylet.
Theinvestigators propose a multi-center randomized trial to compare first-attempt bougie use versus endotracheal tube with stylet use for tracheal intubation of critically ill adults in the ED and ICU.
Read the detailed description
The BOUGIE trial is a prospective, parallel group, pragmatic, randomized trial comparing the effect of bougie use versus endotracheal tube with stylet use on the incidence of successful intubation on the first attempt among adults undergoing urgent or emergent tracheal intubation.
Patients admitted to the study units who are deemed by their clinical team to require intubation and fulfill inclusion criteria without meeting exclusion criteria will be randomized 1:1 to use of a bougie or use of an endotracheal tube and stylet on the first attempt at intubation. All other decisions regarding airway management, including the choice to use a bougie or endotracheal tube and stylet on subsequent attempts, will remain at the discretion of the treating provider.
The trial will enroll 1,106 patients. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 553 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan, which will be submitted for publication or made publicly available prior to the conclusion of enrollment.
The primary outcome is successful intubation on the first attempt
The secondary outcome is severe hypoxemia (lowest arterial oxygen saturation between induction and two minutes following intubation of less than 80%)
- Conditions
- Acute Respiratory Failure
- Being tested
- Bougie, Endotracheal Tube with Stylet
- Keywords
- Intubation, Bougie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BougieOther
disposable tracheal tube introducer of approximately 70 cm in length
Endotracheal Tube with StyletOther
endotracheal tube preloaded with a removable, malleable stylet
| Study group | Role | What they receive |
|---|---|---|
| BOUGIE | Active comparator | For patients randomized to use of a bougie, the operator will use a bougie on the first attempt at intubation. If successful, an assistant will load an endotracheal tube over the bougie, and the operator (without removing the laryngoscope from the mouth) will guide the tube through the vocal cords to the desired depth in the trachea.
If the bougie is not successfully placed in the trachea or the endotracheal tube cannot be successfully advanced over the bougie on the first attempt at intubation, the operator may use any approach during subsequent attempts at tracheal intubation. Receives: Other: Bougie |
| Endotracheal Tube with Stylet | Active comparator | For patients randomized to use of an endotracheal tube with stylet, the operator will use an endotracheal tube containing a removeable, malleable stylet, on the first attempt at intubation.
Manipulation of the shape/curve of the endotracheal tube with stylet is at the discretion of the operator, however a "straight-to-cuff" shape and a bend angle of 25° to 35° is encouraged. The stylet will be left in place until the tube is advanced to the trachea.
If the endotracheal tube with stylet is not successfully placed in the trachea on the first attempt at intubation, the operator may use any approach during subsequent attempts at tracheal intubation. Receives: Other: Endotracheal Tube with Stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intubations with successful intubation on the first attempt
The primary outcome is successful intubation on the first attempt. Successful intubation on the first attempt is defined as placement of an endotracheal tube in the trachea (confirmed by standard means including capnography) following: (1) a single insertion of a laryngoscope blade into the mouth and (2) EITHER a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth OR a single insertion of an endotracheal tube with stylet into the mouth.
Measured: from induction to 2 minutes following tracheal intubation
Secondary outcomes (1)
Number of intubations with severe hypoxemia
Defined as an oxygen saturation less than 80% during the time interval from induction to two minutes after completion of the intubation procedure
Measured: from induction to 2 minutes following tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start29 Apr 2019
- Primary completion14 Feb 2021
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Casey, Vanderbilt University Medical Center
- Investigators
- Jonathan D Casey, MD, Study director, Vanderbilt University Medical CenterMatthew W Semler, MD, MSc, Study chair, Vanderbilt University Medical CenterBrian E Driver, MD, Principal investigator, Hennepin County Medical Center, MinneapolisMatthew E Prekker, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928925
- Sponsor's protocol ID
- 182123
- Acronym
- BOUGIE
- Status last verified
- Mar 2021
- First submitted
- 19 Apr 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.
PubMed 29800096Driver BE, Semler MW, Self WH, Ginde AA, Trent SA, Gandotra S, Smith LM, Page DB, Vonderhaar DJ, West JR, Joffe AM, Mitchell SH, Doerschug KC, Hughes CG, High K, Landsperger JS, Jackson KE, Howell MP, Robison SW, Gaillard JP, Whitson MR, Barnes CM, Latimer AJ, Koppurapu VS, Alvis BD, Russell DW, Gibbs KW, Wang L, Lindsell CJ, Janz DR, Rice TW, Prekker ME, Casey JD; BOUGIE Investigators and the Pragmatic Critical Care Research Group. Effect of Use of a Bougie vs Endotracheal Tube With Stylet on Successful Intubation on the First Attempt Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2488-2497. doi: 10.1001/jama.2021.22002.
PubMed 34879143Driver B, Semler MW, Self WH, Ginde AA, Gandotra S, Trent SA, Smith LM, Gaillard JP, Page DB, Whitson MR, Vonderhaar DJ, Joffe AM, West JR, Hughes C, Landsperger JS, Howell MP, Russell DW, Gulati S, Bentov I, Mitchell S, Latimer A, Doerschug K, Koppurapu V, Gibbs KW, Wang L, Lindsell CJ, Janz D, Rice TW, Prekker ME, Casey JD; BOUGIE Investigators# and the Pragmatic Critical Care Research Group. BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial. BMJ Open. 2021 May 25;11(5):e047790. doi: 10.1136/bmjopen-2020-047790.
PubMed 34035106
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE): a Randomized, Multi-center Trial
- ClinicalTrials.gov ID
- NCT03928925
- Acronym / sponsor ID
- BOUGIE / 182123
- Conditions
- Acute Respiratory Failure
- Keywords
- Intubation, Bougie
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,106 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 14 Feb 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 26 Apr 2019 (actual)
- 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.
Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt during tracheal intubations outside of the operating room is less than 90%. The bougie, a thin semi-rigid tube that can be placed into the trachea, allowing a Seldinger-like technique of intubating a patient's airway, has been traditionally reserved for difficult or failed airways. However, a recent single center trial of adult patients intubated in an emergency department demonstrated that use of the bougie on the first attempt improved intubation success, compared to use of a traditional stylet.
Theinvestigators propose a multi-center randomized trial to compare first-attempt bougie use versus endotracheal tube with stylet use for tracheal intubation of critically ill adults in the ED and ICU.
Detailed description
The BOUGIE trial is a prospective, parallel group, pragmatic, randomized trial comparing the effect of bougie use versus endotracheal tube with stylet use on the incidence of successful intubation on the first attempt among adults undergoing urgent or emergent tracheal intubation.
Patients admitted to the study units who are deemed by their clinical team to require intubation and fulfill inclusion criteria without meeting exclusion criteria will be randomized 1:1 to use of a bougie or use of an endotracheal tube and stylet on the first attempt at intubation. All other decisions regarding airway management, including the choice to use a bougie or endotracheal tube and stylet on subsequent attempts, will remain at the discretion of the treating provider.
The trial will enroll 1,106 patients. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 553 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan, which will be submitted for publication or made publicly available prior to the conclusion of enrollment.
The primary outcome is successful intubation on the first attempt
The secondary outcome is severe hypoxemia (lowest arterial oxygen saturation between induction and two minutes following intubation of less than 80%)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOUGIE | Active comparator | Other: BougieFor patients randomized to use of a bougie, the operator will use a bougie on the first attempt at intubation. If successful, an assistant will load an endotracheal tube over the bougie, and the operator (without removing the laryngoscope from the mouth) will guide the tube through the vocal cords to the desired depth in the trachea. If the bougie is not successfully placed in the trachea or the endotracheal tube cannot be successfully advanced over the bougie on the first attempt at intubation, the operator may use any approach during subsequent attempts at tracheal intubation. |
| Endotracheal Tube with Stylet | Active comparator | Other: Endotracheal Tube with StyletFor patients randomized to use of an endotracheal tube with stylet, the operator will use an endotracheal tube containing a removeable, malleable stylet, on the first attempt at intubation. Manipulation of the shape/curve of the endotracheal tube with stylet is at the discretion of the operator, however a "straight-to-cuff" shape and a bend angle of 25° to 35° is encouraged. The stylet will be left in place until the tube is advanced to the trachea. If the endotracheal tube with stylet is not successfully placed in the trachea on the first attempt at intubation, the operator may use any approach during subsequent attempts at tracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is located in a participating unit of an adult hospital
- Planned procedure is tracheal intubation with sedative administration (or tracheal intubation without sedative administration during cardiac arrest)
- Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
- Planned laryngoscopy device is a non-hyperangulated laryngoscope blade
Key exclusion criteria (6 listed)
- Patient is pregnant
- Patient is a prisoner
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an approach to intubation other than use of a bougie or use of an endotracheal tube with stylet would be best for the care of the patient
- Operator feels use of a bougie is required or contraindicated for the care of the patient
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 |
|---|---|---|
| Bougiedisposable tracheal tube introducer of approximately 70 cm in length | Other | BOUGIE |
| Endotracheal Tube with Styletendotracheal tube preloaded with a removable, malleable stylet | Other | Endotracheal Tube with Stylet |
Primary outcome
Number of intubations with successful intubation on the first attempt
Time frame: from induction to 2 minutes following tracheal intubation
The primary outcome is successful intubation on the first attempt. Successful intubation on the first attempt is defined as placement of an endotracheal tube in the trachea (confirmed by standard means including capnography) following: (1) a single insertion of a laryngoscope blade into the mouth and (2) EITHER a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth OR a single insertion of an endotracheal tube with stylet into the mouth.
1 secondary outcome
Number of intubations with severe hypoxemia
Time frame: from induction to 2 minutes following tracheal intubation
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 22 Mar 2021.
- Background: PubMed 29800096Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.
- Derived from this study: PubMed 34879143Driver BE, Semler MW, Self WH, Ginde AA, Trent SA, Gandotra S, Smith LM, Page DB, Vonderhaar DJ, West JR, Joffe AM, Mitchell SH, Doerschug KC, Hughes CG, High K, Landsperger JS, Jackson KE, Howell MP, Robison SW, Gaillard JP, Whitson MR, Barnes CM, Latimer AJ, Koppurapu VS, Alvis BD, Russell DW, Gibbs KW, Wang L, Lindsell CJ, Janz DR, Rice TW, Prekker ME, Casey JD; BOUGIE Investigators and the Pragmatic Critical Care Research Group. Effect of Use of a Bougie vs Endotracheal Tube With Stylet on Successful Intubation on the First Attempt Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2488-2497. doi: 10.1001/jama.2021.22002.
- Derived from this study: PubMed 34035106Driver B, Semler MW, Self WH, Ginde AA, Gandotra S, Trent SA, Smith LM, Gaillard JP, Page DB, Whitson MR, Vonderhaar DJ, Joffe AM, West JR, Hughes C, Landsperger JS, Howell MP, Russell DW, Gulati S, Bentov I, Mitchell S, Latimer A, Doerschug K, Koppurapu V, Gibbs KW, Wang L, Lindsell CJ, Janz D, Rice TW, Prekker ME, Casey JD; BOUGIE Investigators# and the Pragmatic Critical Care Research Group. BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial. BMJ Open. 2021 May 25;11(5):e047790. doi: 10.1136/bmjopen-2020-047790.
- Individual participant dataSharing planned: Yes
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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.
Jonathan D Casey, MD study director
Vanderbilt University Medical Center
Matthew W Semler, MD, MSc study chair
Vanderbilt University Medical Center
Brian E Driver, MD principal investigator
Hennepin County Medical Center, Minneapolis
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bougie and Endotracheal Tube with Stylet in people with Acute Respiratory Failure, run by Vanderbilt University Medical Center at 11 sites 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 4 inclusion and 6 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 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?
Number of intubations with successful intubation on the first attempt (time frame: from induction to 2 minutes following tracheal intubation). 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 NCT03928925, which also lists 3 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 Mar 2021.