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Completed

NCT Number: NCT04833166

Comparing Full vs. Partial Glottis View Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient

Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide an optimal glottic view for intubation. However, in cervical spine patients, this alignment is not possible thus resulting in an increased risk of fail intubations.

D-blade comes with an elliptically tapered blade shape rising at the distal end to provide better glottic visualization in comparison with direct laryngoscopes. Hence, CMAC D-blade is preferred in simulated cervical spine injury where intubator needs to maintain a neutral neck position. However, intubation time may be significantly longer due to difficulty in negotiating the endotracheal tube pass vocal cord and impingement of endotracheal tube to the anterior wall of trachea.

There is a study published Glidescope which is also a hyperangulated videolaryngoscope suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. The aim of this study is to clinically evaluate the time of tracheal intubation in relation to the full glottic view vs. partial glottic view which is deliberately obtained when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, 58200, Malaysia

About this study

Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide the best laryngeal view for intubation. In cervical spine patients, this alignment is not possible resulting in an increased risk of failed intubations. Difficult intubation and failed tracheal intubation are among the major causes of morbidity and mortality associated with anesthesia.

In recent years, video laryngoscope has played an increasingly important role in the management of patients with unanticipated difficult or failed endotracheal intubation. When compared with a direct laryngoscope, the video laryngoscope achieved a better view of the glottis and a high rate of successful intubation.

On comparing the C-MAC with the conventional Macintosh blade, a conventional C-MAC Macintosh blade 3 and D-blade have a blade angulation of 18° and 40° in the D-blade respectively. In addition, with D-blade is an elliptically tapered blade-shaped rising to distal.

This highly angulated C-MAC D blade provides a better glottic visualization in comparison to the direct laryngoscopes and in simulated cervical spine injury. This resulted in successful intubation in routine induction of anesthesia and rescue intubation in patients with difficult airway with C-MAC D Blade. But in terms of intubation time, study has shown a significantly shorter time with C-MAC D Blade compared with other indirect laryngoscopes. This may be due to a common problem seen in indirect video laryngoscopy whereby a good glottic view does not always allow advancing the tube into the trachea.

A study has been conducted on Glidescope which is also a hyperangulated blade suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. Randomised controlled trial also showed that GlideScope and C-MAC D blade video laryngoscope using manual inline axial stabilization (MIAS) for tracheal intubation in patients with cervical spine injury/pathology were equally efficacious.

The aim of this study is to clinically evaluate the time of tracheal intubation in relation to deliberately obtained full glottic view vs. partial glottic view when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with American Society of Anaesthesiologist (ASA) physical status I-III
  • Age (≥21-75 years old)
  • General anaesthesia requiring tracheal intubation
  • Provide written consent to participate in the study

Exclusion criteria

  • Pregnancy
  • Body mass index (BMI) ≥ 35
  • Condition requires rapid sequence induction
  • Need for fibreoptic intubation
  • Need for nasal intubation
  • Documented difficult airway during previous surgery
  • Recent (3 months) active ischemic heart disease
  • Recent (3 months) cerebrovascular disease
  • Acute exacerbation of respiratory disease (eg. Uncontrolled asthma, Chronic Obstructive Pulmonary Disease)

Treatment and study plan

CMAC D-blade videolaryngoscope with full or partial glottic view

Device

Deliberate achieving full or partial glottic view on C MAC D-blade video laryngoscope and comparing time and ease of intubation with both arms

Primary outcomes

  1. Intubation time

    Time frame: during the intervention

    This is the time taken from CMAC laryngoscope blade passes patient's lip until the recording of first end tidal CO2 (EtCO2); assessed up to 120 seconds.

  2. First attempt successful intubation attempt

    Time frame: during the intervention

    First intubation attempt success rate between two groups; assessed up to maximum 2 attempts

Secondary outcomes

  1. Time to obtain glottic view

    Time frame: during the intervention

    Time taken for from CMAC laryngoscope blade passes patient's lip until achieving assigned laryngoscopic view; assessed up to 120 seconds

  2. Hemodynamic changes

    Time frame: immediately after the intervention

    Blood pressure, mean arterial pressure and heart rate recorded 1 min, 2.5 min then 5 min post intubation

  3. Airway trauma

    Time frame: immediately after the surgery

    Incidence of oral mucosal trauma, lip laceration, dental laceration; assessed up to discharge from operating theatre.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Full Glottis View vs. Partial Glottis View During Intubation Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2021
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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