Respiratory FailurePreVentNCT03026322
Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial
A study testing Manual Ventilation and No Manual Ventilation in people with Respiratory Failure and Respiratory Failure With Hypoxia, run by Vanderbilt University Medical Center at 5 sites in United States.
Trial summary
Complications are common during endotracheal intubation of critically ill adults. Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Respiratory Failure With Hypoxia, Endotracheal Intubation
- What is being tested?
- Manual Ventilation and No Manual Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Mar 2017to 6 Jul 2018
- 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
- Planned procedure is endotracheal intubation
- Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Who cannot join
- Urgency of intubation precludes safe performance of study procedures
- Operator feels a specific approach to ventilation between induction and intubation is required
- Pregnant women
- Prisoners
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Vanderbilt University Medical Center
Nashville, Tennessee, 37209
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112
Ochsner Health System
New Orleans, Louisiana, 70121
Harborview Medical Center, University of Washington
Seattle, Washington, 98104
About this study
Complications are common during endotracheal intubation of critically ill adults. Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults. The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.
Read the detailed description
PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults. The primary aim of the PreVent trial is to compare the effect of manual ventilation between induction and intubation versus no manual ventilation on the lowest arterial oxygen saturation experienced by critically ill adults undergoing endotracheal intubation. The PreVent trial is anticipated to begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation with sedation and/or neuromuscular blockade in participating units. Patients will be randomized 1:1 to manual ventilation versus no manual ventilation. In the manual ventilation group, manual ventilation using a bag-valve-mask will be provided from the time of induction until the time of endotracheal intubation, except during laryngoscopy. In the no manual ventilation group, no manual ventilation will be provided between induction and endotracheal intubation, except for the treatment of hypoxemia. The primary efficacy endpoint will be the lowest arterial oxygen saturation during the procedure. The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure in the 24 hours after intubation. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 175 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan made publicly available prior to the conclusion of enrollment. The initial planned enrollment of 350 patients was increased by the Data and Safety Monitoring Board at the interim analysis to a final planned enrollment of 400 patients.
- Being tested
- Manual Ventilation, No Manual Ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual VentilationOther
Also called Bag-valve-mask ventilation
Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
No Manual VentilationOther
Also called Apnea
Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
| Study group | Role | What they receive |
|---|---|---|
| Manual Ventilation | Active comparator | Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts. Receives: Other: Manual Ventilation |
| No Manual Ventilation | Active comparator | Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided. Receives: Other: No Manual Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest arterial oxygen saturation
The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
Measured: Induction to 2 minutes after completion of the airway management procedure
Secondary outcomes (26)
Incidence of lowest oxygen saturation less than 90%
Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.
Measured: Induction to 2 minutes after completion of the airway management procedure
Incidence of lowest oxygen saturation less than 80%
Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.
Measured: Induction to 2 minutes after completion of the airway management procedure
Change in saturation from induction to lowest oxygen saturation
Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
Measured: Induction to 2 minutes after completion of the airway management procedure
Incidence of desaturation
Incidence of desaturation as defined by a decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
Measured: Induction to 2 minutes after completion of the airway management procedure
Lowest oxygen saturation in the 24 hours after intubation.
Measured: 24 hours after intubation
Highest fraction of inspired oxygen in the 24 hours after intubation.
Measured: 24 hours after intubation
Highest positive end expiratory pressure in the 24 hours after intubation.
Measured: 24 hours after intubation
Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
Measured: 24 hours after intubation
Operator-reported pulmonary aspiration
Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.
Measured: Induction to 2 minutes after completion of the airway management procedure
New infiltrate on chest imaging in the 48 hours after intubation
Determination of new infiltrate will be made by two blinded experts (pulmonary/critical care attendings or fellows) with adjudication by a third expert in the case of discordant results
Measured: 48 hours after intubation
Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
Measured: 48 hours after intubation
New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
Measured: 24 hours after intubation
Incidence of esophageal intubation
Measured: Induction to 2 minutes after completion of the airway management procedure
Lowest systolic blood pressure (peri-procedural)
Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure
Measured: Induction to 2 minutes after completion of the airway management procedure
New systolic blood pressure < 65 mmHg or new need for vasopressor
New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube
Measured: Induction to 2 minutes after completion of the airway management procedure
Cardiac arrest within one hour of intubation
Measured: One hour after intubation.
Death within one hour of intubation
Measured: One hour after intubation
Cormack-Lehane grade of glottic view
Measured: Induction to 2 minutes after completion of the airway management procedure
Operator-assessed difficulty of intubation
Measured: Induction to 2 minutes after completion of the airway management procedure
Incidence of successful intubation on the first laryngoscopy attempt
Measured: Induction to 2 minutes after completion of the airway management procedure
Number of laryngoscopy attempts
Measured: Induction to 2 minutes after completion of the airway management procedure
Time from induction to successful intubation
Measured: Induction to 2 minutes after completion of the airway management procedure
Need for additional airway equipment or a second operator
Measured: Induction to 2 minutes after completion of the airway management procedure
In-hospital mortality
Measured: 28 days
Ventilator-free days
Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing. If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28. If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0. If a patient is discharged while receiving assisted ventilation, VFD will be 0. All data will be censored at the first of hospital discharge or 28 days.
Measured: 28 days
Intensive care unit-free days
ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit in that hospitalization before 28 days. Patients who are never discharged from the intensive care unit will receive a value of 0. Patients who die before day 28 will receive a value of 0. For patients who return to an ICU and are subsequently discharged prior to day 28, ICU-free days will be counted from the date of final ICU discharge. All data will be censored at the first of hospital discharge or 28 days.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start15 Mar 2017
- Primary completion6 May 2018
- Study completion6 Jul 2018
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Semler, Vanderbilt University Medical Center
- Investigators
- Matthew W Semler, MD, MSc, Study director, Vanderbilt University Medical CenterTodd W Rice, MD, MSc, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026322
- Sponsor's protocol ID
- IRB #161962
- Acronym
- PreVent
- Status last verified
- Sep 2018
- First submitted
- 16 Jan 2017
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
PubMed 30779528Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.
PubMed 30099400
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial
- ClinicalTrials.gov ID
- NCT03026322
- Acronym / sponsor ID
- PreVent / IRB #161962
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 20 Jan 2017 (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.
Complications are common during endotracheal intubation of critically ill adults. Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults. The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.
Detailed description
PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults. The primary aim of the PreVent trial is to compare the effect of manual ventilation between induction and intubation versus no manual ventilation on the lowest arterial oxygen saturation experienced by critically ill adults undergoing endotracheal intubation. The PreVent trial is anticipated to begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation with sedation and/or neuromuscular blockade in participating units. Patients will be randomized 1:1 to manual ventilation versus no manual ventilation. In the manual ventilation group, manual ventilation using a bag-valve-mask will be provided from the time of induction until the time of endotracheal intubation, except during laryngoscopy. In the no manual ventilation group, no manual ventilation will be provided between induction and endotracheal intubation, except for the treatment of hypoxemia. The primary efficacy endpoint will be the lowest arterial oxygen saturation during the procedure. The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure in the 24 hours after intubation. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 175 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan made publicly available prior to the conclusion of enrollment. The initial planned enrollment of 350 patients was increased by the Data and Safety Monitoring Board at the interim analysis to a final planned enrollment of 400 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Ventilation | Active comparator | Other: Manual VentilationBeginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts. |
| No Manual Ventilation | Active comparator | Other: No Manual VentilationBetween the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is located in a participating unit
- Planned procedure is endotracheal intubation
- Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Key exclusion criteria (4 listed)
- Urgency of intubation precludes safe performance of study procedures
- Operator feels a specific approach to ventilation between induction and intubation is required
- Pregnant women
- Prisoners
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 |
|---|---|---|
| Manual VentilationAlso: Bag-valve-mask ventilationBeginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts. | Other | Manual Ventilation |
| No Manual VentilationAlso: ApneaBetween the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided. | Other | No Manual Ventilation |
Primary outcome
Lowest arterial oxygen saturation
Time frame: Induction to 2 minutes after completion of the airway management procedure
The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
26 secondary outcomes
Incidence of lowest oxygen saturation less than 90%
Time frame: Induction to 2 minutes after completion of the airway management procedure
Incidence of lowest oxygen saturation less than 80%
Time frame: Induction to 2 minutes after completion of the airway management procedure
Change in saturation from induction to lowest oxygen saturation
Time frame: Induction to 2 minutes after completion of the airway management procedure
Incidence of desaturation
Time frame: Induction to 2 minutes after completion of the airway management procedure
Lowest oxygen saturation in the 24 hours after intubation.
Time frame: 24 hours after intubation
Highest fraction of inspired oxygen in the 24 hours after intubation.
Time frame: 24 hours after intubation
Highest positive end expiratory pressure in the 24 hours after intubation.
Time frame: 24 hours after intubation
Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
Time frame: 24 hours after intubation
Operator-reported pulmonary aspiration
Time frame: Induction to 2 minutes after completion of the airway management procedure
New infiltrate on chest imaging in the 48 hours after intubation
Time frame: 48 hours after intubation
Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
Time frame: 48 hours after intubation
New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
Time frame: 24 hours after intubation
Incidence of esophageal intubation
Time frame: Induction to 2 minutes after completion of the airway management procedure
Lowest systolic blood pressure (peri-procedural)
Time frame: Induction to 2 minutes after completion of the airway management procedure
New systolic blood pressure < 65 mmHg or new need for vasopressor
Time frame: Induction to 2 minutes after completion of the airway management procedure
Cardiac arrest within one hour of intubation
Time frame: One hour after intubation.
Death within one hour of intubation
Time frame: One hour after intubation
Cormack-Lehane grade of glottic view
Time frame: Induction to 2 minutes after completion of the airway management procedure
Operator-assessed difficulty of intubation
Time frame: Induction to 2 minutes after completion of the airway management procedure
Incidence of successful intubation on the first laryngoscopy attempt
Time frame: Induction to 2 minutes after completion of the airway management procedure
Number of laryngoscopy attempts
Time frame: Induction to 2 minutes after completion of the airway management procedure
Time from induction to successful intubation
Time frame: Induction to 2 minutes after completion of the airway management procedure
Need for additional airway equipment or a second operator
Time frame: Induction to 2 minutes after completion of the airway management procedure
In-hospital mortality
Time frame: 28 days
Ventilator-free days
Time frame: 28 days
Intensive care unit-free days
Time frame: 28 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 13 Sep 2018.
- Derived from this study: PubMed 30779528Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
- Derived from this study: PubMed 30099400Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.
Related trials for Respiratory Failure
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
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Matthew W Semler, MD, MSc study director
Vanderbilt University Medical Center
Todd W Rice, MD, MSc principal investigator
Vanderbilt University Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Ventilation and No Manual Ventilation in people with Respiratory Failure and Respiratory Failure With Hypoxia, run by Vanderbilt University Medical Center at 5 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 5 inclusion and 4 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Lowest arterial oxygen saturation (time frame: Induction to 2 minutes after completion of the airway management procedure). 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 NCT03026322, 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 13 Sep 2018.