ASIGN Trial- Angulated Versus Standard Video-laryngoscope Blade in Nasal Intubation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

This study compares two videolaryngoscope blade designs for nasal tracheal intubation in patients undergoing surgery under general anesthesia. Participants will be randomly assigned to undergo nasal tracheal intubation using either a hyperangulated C-MAC® D-BLADE® or a Macintosh-style videolaryngoscope blade.

The study will evaluate the effectiveness of each approach by measuring time to successful intubation, number of intubation attempts, airway maneuvers required, and other procedural outcomes. Safety outcomes, including airway- and anesthesia-related adverse events, will also be assessed. The findings may help identify the most effective and safe videolaryngoscope blade design for nasal tracheal intubation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Patients requiring awake fiber optic intubation

Emergency cases

High risk of aspiration

Bleeding diathesis

Trial design

Design model

Parallel

Treatments tested in this trial

  • C-MAC® Videolaryngoscope D-BLADE®

    Device

    The C-MAC® Videolaryngoscope D-BLADE® is a hyperangulated videolaryngoscope blade used for nasal tracheal intubation. Participants randomized to this intervention will undergo their initial study intubation attempt using the assigned D-BLADE® following induction of general anesthesia.

  • C-MAC® Videolaryngoscope Macintosh Blade

    Device

    The C-MAC® Videolaryngoscope Macintosh Blade is a Macintosh-style videolaryngoscope blade used for nasal tracheal intubation. Participants randomized to this intervention will undergo their initial study intubation attempt using a size 3 or size 4 Macintosh blade, as clinically appropriate, following induction of general anesthesia.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: C-MAC© Videolaryngoscope D-BladeExperimental treatment 1 intervention
Group B: C-MAC© Videolaryngoscope MacintoshExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of adjunct maneuvers for nasal intubation.

Time from insertion of the videolaryngoscope blade into the mouth to confirmation of successful tracheal intubation by three consecutive end-tidal carbon dioxide waveforms.

Time frame
Day 0 (surgery day), during the intubation procedure on the day of surgery

Secondary outcomes

1

First-pass success rate

The proportion of participants in whom successful nasal tracheal intubation is achieved on the first intubation attempt.

Time frame
Day 0 (surgery day), during the intubation procedure on the day of surgery
2

Total time for intubation

The total time required to achieve successful nasal tracheal intubation, measured from insertion of the videolaryngoscope blade into the mouth to confirmation of successful intubation by three consecutive end-tidal carbon dioxide waveforms.

Time frame
Day 0 (surgery day), during the intubation procedure on the day of surgery
3

Number of adjunct maneuvers required for successful nasal intubation

The number and type of adjunct maneuvers required to achieve successful nasal tracheal intubation, including maneuvers such as tube rotation, external laryngeal manipulation, head positioning, cuff insufflation, use of McGill forceps, bougie use, or other documented techniques.

Time frame
Day 0 (surgery day), during the intubation procedure on the day of surgery
4

Total number of intubation attempts

The total number of intubation attempts required to achieve successful nasal tracheal intubation. Each insertion of the videolaryngoscope blade will be considered one intubation attempt.

Time frame
Day 0 (surgery day), during the intubation procedure on the day of surgery

Other outcomes

Sponsors and contacts

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