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OpenTrials
Completed

NCT Number: NCT02733536

Intubation During Spinal Immobilization

The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed in patients with immobilized cervical spine by unexperienced physicians.

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Key information

Conditions

Endotracheal Intubation Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, Poland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • give voluntary consent to participate in the study
  • limited experience (<5 intubations) with "real-life" intubation using direct laryngoscopy
  • novice phhysicians

Exclusion criteria

  • not meet the above criteria
  • practice with any videolaryngoscopy
  • wrist or low back diseases
  • pregnancy

Treatment and study plan

Standard endotracheal tube

Device
  • Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube

C-MAC

Device

C-MAC introduced with a h size 3 blade.

Primary outcomes

  1. Time required for successful intubation

    Time frame: 1 day

Secondary outcomes

  1. success rate of intubation attempt

    Time frame: 1 day

    success rate of first intubation attempt

  2. Cormack&Lehane grade

    Time frame: 1 day

    glottic view during intubation rate using Cormack&Lehane grade

  3. Dental Compression

    Time frame: 1 day

    the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)

  4. Ease of intubation

    Time frame: 1 day

    To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

C-MAC Compared to Direct Laryngoscopy in Patients With Immobilized Cervical Spine by Unexperienced Physicians: A Randomized Crossover Manikin Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2016
Registry last updated
Jul 27, 2017

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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