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

September 10, 2026 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Comparison Between C-MAC© Videolaryngoscope D-Blade Versus C-MAC© Videolaryngoscope Macin-tosh for Nasal Intubation. A Prospective Randomized Clinical 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

ASIGN is a prospective, single-blinded randomized single-center study to be conducted at Mount Sinai Hospital comparing hyperangulated blades versus Macintosh style videolaryngoscope blades for nasal intuba-tion The study will aim to enroll 220 patients, 110 on each treatment arm.

Patients who meet the inclusion criteria will be identified on the day of surgery and consent will be ob-tained from these patients. Once eligibility is confirmed, the research coordinator will randomize the pa-tient to one of two groups: C-MAC© Videolaryngoscope D-Blade or the C-MAC© Videolaryngoscope Mac-intosh blade.

All study participants will receive the same perioperative management which will include nasal vasoconstriction with xylometazoline 0.05% nasal spray. Three sprays will be given in each nostril prior to the patient entering the operating room. The choice of nostril for the nasal intubation will be made according to the pre-assessment with the patient and radiology imaging available.

To minimize the risk of operator-related bias during the procedure, the data collection will be collected by a member of the research team. All intubations will be performed by an anesthesiologist with more than 3 years of experience in using Macintosh videolaryngoscope, hyperangulated videolaryngoscope, nasal intubation and adjunct maneuvers.

Standard monitoring of vital signs will be used, including non-invasive blood pressure, pulse oxygen saturation, cardioscope, end-tidal carbon dioxide waveform, and neuromuscular transmission (NMT). Additional monitoring will be left to the criteria of the attending anesthesiologist. All subjects will be preoxygenated to an end-tidal oxygen fraction above 80%. The head will be supported in a headgel pillow in the extended position in a way that the patient is comfortable prior to the induction and head elevation between 5 to 10 cm.

Polar® North Polar Tubes (Smiths Medical, Minneapolis, USA), internal diameter 6.0 or 7.0 millimetre, are available and pre-warmed in the operation room. After the induction of general anesthesia, the anesthesiologist will nominate their first choice of size for the nasal endotracheal tube based on the weight and height of the patient. Once the NMT shows a train-of-four (TOF) = 0, the nostril will be lubricated with a water-based solution and the nasal tube will be advanced over until the tip is present in the oropharynx. After the insertion of the tube through the nostril, the anesthesiologist will use the de videolaryngoscope assigned for each group.

The patients allocated to the hyperangulated videolaryngoscope group will have C-MAC D-BLADE© (Karl Storz SE & Co. KG, Tuttlingen, Germany) as the tool for nasal intubation. Whereas the Macintosh-style videolaryngoscopy group will have a C-MAC© size 3 or 4 Macintosh blade (Karl Storz SE & Co. KG).

In case of hypoxemia, defined as pulse oxygen saturation < 90%, the intubation attempt will be interrupted, and mask ventilation will be reinitiated. If tracheal intubation fails after the third attempt, intubation with an alternative device would be attempted. If intubation is not possible, the patient will be awakened.

The study will be stopped early in the occurrence of any of the following: arterial active epistaxis bleeding, bronchospasm and laryngospasm that create difficulty ventilation even after deepen the anes-thesia and the use of muscle relaxant medication, refractory hypotension regardless the use of vasopres-sors, bradycardia below forty heart beats per minute with no response from anticholinergic medication, sustained hypertension regardless the use of vasodilators, sustained cardiac arrhythmia, - allergic reac-tion, failed facemask ventilation after using oropharyngeal airway plus two-hand seal mask technique, or rescuing the airway with a supraglottic device or front of neck access surgical airway.

The study will be interrupted in one of the following situations: nasal intubation is not possible due to size of the tube, necessity for intubation with nasal RAE (Ring-Adair-Elwyn) tube or necessity of oral endotracheal intubation.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kong E You-Ten, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

1. Patients 18 years old or above

Exclusion Criteria:

  1. Patients requiring awake fiber optic intubation
  2. Emergency cases
  3. High risk of aspiration
  4. Bleeding diathesis
  5. Abnormal nasal anatomy
  6. Chronic Epistaxis
  7. Severe cardiorespiratory disease
  8. Basilar skull fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C-MAC© Videolaryngoscope D-Blade
Participants randomized to this arm will undergo nasal tracheal intubation using the C-MAC® Videolaryngoscope D-BLADE®, a hyperangulated videolaryngoscope blade. The assigned device will be used for the initial study intubation attempt following induction of general anesthesia. Intubation will be performed according to the study protocol, with procedural outcomes including time to successful intubation, number of attempts, and airway maneuvers recorded
Device: C-MAC® Videolaryngoscope D-BLADE®
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.
Experimental: C-MAC© Videolaryngoscope Macintosh
Participants randomized to this arm will undergo nasal tracheal intubation using a C-MAC® Videolaryngoscope with a Macintosh-style blade (size 3 or size 4, as clinically appropriate). The assigned device will be used for the initial study intubation attempt following induction of general anesthesia. Intubation will be performed according to the study protocol, with procedural outcomes including time to successful intubation, number of attempts, and airway maneuvers recorded.
Device: C-MAC® Videolaryngoscope Macintosh Blade
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adjunct maneuvers for nasal intubation.
Time Frame: Day 0 (surgery day), during the intubation procedure on the day of surgery
Time from insertion of the videolaryngoscope blade into the mouth to confirmation of successful tracheal intubation by three consecutive end-tidal carbon dioxide waveforms.
Day 0 (surgery day), during the intubation procedure on the day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First-pass success rate
Time Frame: Day 0 (surgery day), during the intubation procedure on the day of surgery
The proportion of participants in whom successful nasal tracheal intubation is achieved on the first intubation attempt.
Day 0 (surgery day), during the intubation procedure on the day of surgery
Total time for intubation
Time Frame: Day 0 (surgery day), during the intubation procedure on the day of surgery
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.
Day 0 (surgery day), during the intubation procedure on the day of surgery
Number of adjunct maneuvers required for successful nasal intubation
Time Frame: Day 0 (surgery day), during the intubation procedure on the day of surgery
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.
Day 0 (surgery day), during the intubation procedure on the day of surgery
Total number of intubation attempts
Time Frame: Day 0 (surgery day), during the intubation procedure on the day of surgery
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.
Day 0 (surgery day), during the intubation procedure on the day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1768

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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