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Clinical Trials/NCT02926144
NCT02926144
Completed
N/A

Can the Use of the McGRATH® MAC Videolaryngoscope Decrease the Number of People Required for Tracheal Intubation in a Population of Patients Without Predicted Difficult Intubation?

Hopital Foch4 sites in 1 country300 target enrollmentNovember 28, 2016
ConditionsAnesthesia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Hopital Foch
Enrollment
300
Locations
4
Primary Endpoint
Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The main objective of this study is to compare the proportion of tracheal intubations for which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.

Detailed Description

Videolaryngoscopes, such as McGRATH® MAC videolaryngoscope, are used to facilitate tracheal intubations. This study is designed to evaluate the proportion of cases requiring more than one member of the anesthesiology team when the video feature of McGRATH® MAC is available during laryngoscopy in a population of patients without a predicted difficult intubation (Arne's score \<11). General anesthesia from induction until tracheal intubation is recorded on a video for further analysis. Analysis includes characteristics of intubation, patient's monitoring and cooperation between anesthesiologists in two groups. In the control group, the screen of the McGRATH® MAC videolaryngoscope is hidden. In the experimental group, the McGRATH® MAC videolaryngoscope is used with its video feature.

Registry
clinicaltrials.gov
Start Date
November 28, 2016
End Date
April 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged 18 years old minimum
  • Requiring general anesthesia and orotracheal intubation with a single lumen tube
  • Having signed an inform consent form
  • Having a telephone and agreeing to communicate their phone number
  • Benefiting from a social insurance scheme or beneficiary

Exclusion Criteria

  • Pregnant or breast-feeding women
  • Patients taken care in ambulatory surgery who could not be contacted within 24 hours following surgery
  • Patients having a predicted difficult intubation (Arné's score ≥ 11) or predicted difficult mask ventilation
  • patients requiring a rapid-sequence intubation
  • patients for whom general anesthesia using sufentanil, propofol, atracurium or rocuronium is not suitable.

Outcomes

Primary Outcomes

Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available

Time Frame: 30 minutes

Intubation is video and audio recorded for further analysis. The availability of the video feature of McGRATH® MAC is hidden from the recording. Only the number of people required and the intubation characteristics can be seen on the video.

Secondary Outcomes

  • Arterial desaturation(30 minutes maximum)
  • Cooperation between members of the anesthesiology team during intubation(30 minutes)
  • Intubation difficulty Scale (IDS)(30 minutes)
  • Number of hands necessary for tracheal intubation(30 minutes)
  • Time to intubate(30 minutes)
  • Esophageal intubation(30 minutes)
  • Intubation failure(30 minutes)
  • Perception of intubation difficulty by the operator(30 minutes)
  • Impact of videolaryngoscopy on hemodynamic variables(30 minutes)
  • Evaluation of usual complications after tracheal intubation(24 hours)

Study Sites (4)

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