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Trial · NCT05239195

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Intubations With Successful Intubation on the First AttemptDuration of procedure (minutes)
The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.
SecondaryNumber of Participants With Severe Complications of Tracheal Intubationfrom induction to 2 minutes following tracheal intubation
The secondary outcome is defined as the number of patients who experienced one or more of the following occurring between induction and 2 minutes after successful intubation: * Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry \< 80%); * Severe hypotension (systolic blood pressure \< 65 mm Hg or new or increased vasopressor administration); * Cardiac arrest not resulting in death within 1 hour of intubation; or * Cardiac arrest resulting in death within 1 hour of induction
OtherDuration of Laryngoscopy and Tracheal IntubationDuration of procedure (minutes)The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of an endotracheal tube or tracheostomy tube in the trachea.
OtherNumber of Laryngoscopy AttemptsDuration of procedure (minutes)
OtherNumber of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal TubeDuration of procedure (minutes)
OtherSuccessful Intubation on the First Attempt Without a Severe Complicationfrom induction to 2 minutes following tracheal intubation
This outcome reports the number of participants that experienced successful intubation on the first attempt without experiencing complications, a composite of two independent outcomes: successful intubation on the first attempt (the primary outcome of the trial) and severe complication (the secondary outcome of the trial).
OtherReason for Failure to Intubate on the First AttemptDuration of procedure (minutes)
Providers could give more than one reason for failure to intubate on the first attempt for each intubation (not mutually exclusive). In addition, data on the reason for failure to intubate on the first attempt was missing for 23 patients in the video laryngoscope group and 40 patients in the direct laryngoscope group. Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt): * Inadequate view of the larynx * Inability to intubate the trachea with an endotracheal tube * Inability to cannulate the trachea with a bougie * Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding) * Technical failure of the laryngoscope (e.g., battery, light source, camera, screen) * Other * Not Reported
OtherOperator-reported Aspirationfrom induction to 2 minutes following tracheal intubation
OtherEsophageal Intubationfrom induction to 2 minutes following tracheal intubation
OtherInjury to the Teethfrom induction to 2 minutes following tracheal intubation
OtherICU-free Days in the First 28 Days28 days
OtherVentilator Free Days in the First 28 Days28 days
OtherAll-cause In-hospital Mortality28 days

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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