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Completed

NCT Number: NCT02926144

Does McGRATH® MAC Videolaryngoscope Decrease the Number of People Required to Perform Intubation During Anesthesia ?

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Hospitalier Franco Britannique, Levallois-Perret, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Laryngoscope with video

Device

Intubation with video-laryngoscope McGrath with use of the video feature

Other names: Endotracheal intubation with laryngoscope video feature

Laryngoscope without video

Device

Endotracheal intubation with video-laryngoscope McGrath without use of the video feature

Other names: Intubation without the laryngoscope video feature

Primary outcomes

  1. 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

  1. Cooperation between members of the anesthesiology team during intubation

    Time frame: 30 minutes

    Based on the video recording: Use of the Kraus Scale (based on "Kraus M, Huang C, Keltner D: Tactile Communication, Cooperation and Performance. Emotion, 2010, 10, 745-9") evaluating communication and gestures within the team

  2. Intubation difficulty Scale (IDS)

    Time frame: 30 minutes

  3. Number of hands necessary for tracheal intubation

    Time frame: 30 minutes

    Based on the video recording: 2 hands when one person intubates by itself without any help, 3 or 4 hands when assistance is given by a second anesthesiologist. 5 to 6 hands when a third person is needed.

  4. Time to intubate

    Time frame: 30 minutes

    Based on the video recording: from the entrance of the blade in the patient's mouth until the presence of the first capnogram

  5. Esophageal intubation

    Time frame: 30 minutes

    No capnograms during mechanical ventilation once intubation is performed

  6. Intubation failure

    Time frame: 30 minutes

    Based on the video recording

  7. Arterial desaturation

    Time frame: 30 minutes maximum

    Based on the video recording: visualisation of a pulse oximetry inferior to 92%

  8. Perception of intubation difficulty by the operator

    Time frame: 30 minutes

    Evaluation on a scale between zero (no difficulty at all) to ten (extremely difficult)

  9. Impact of videolaryngoscopy on hemodynamic variables

    Time frame: 30 minutes

    Based on the video recording: Blood pressure and heart beat on monitoring before and after video laryngoscopy

  10. Evaluation of usual complications after tracheal intubation

    Time frame: 24 hours

    Sore throat or voice change noticed on day 1

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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?

Acronym: MGM3

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2016
Registry last updated
Oct 28, 2021

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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