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OpenTrials
Completed

NCT Number: NCT02297113

Rapid Sequence Intubation at the Emergency Department

All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department will be screened for inclusion in this clinical study. The indication of endotracheal intubation is an exclusively clinical decision and is not affected by this study protocol in any aspect.

If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of two groups

1. C-MAC Videolaryngoscope in appropriate size 2. conventional endotracheal intubation using Macintosh Blade in appropriate size

Randomization (1:1) will be based on computer-generated codes maintained in sequentially numbered opaque envelopes that will be opened immediately before randomization.

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Key information

Conditions

Emergency Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zuerich, Dept of Anesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients requiring emergency Rapid Sequence Intubation at the emergency department
  • Male and Female subjects 18 years to 99 years of age
  • Written confirmation by a physician not involved in this study
  • Written informed consent by the participant (obtained afterwards)
  • Patient not showing remarkable rejection in participation in this study

Exclusion criteria

  • Maxilla-Facial trauma
  • Immobilized cervical spine
  • Indication for fiberoptic guided intubation (known difficult airway)
  • Ongoing Cardio-Pulmonary-Resuscitation (CPR)
  • Involvement in any other clinical trial during the course of this trial, within a period of 30 days prior to its beginning or 30 days after its completion
  • Severe or immediately life-treating injury requiring immediate medical treatment

Treatment and study plan

Macintosh Blade

Device

conventional endotracheal intubation

C-MAC videolaryngoscope

Device

Primary outcomes

  1. Success Rate

    Time frame: 10 minutes

    defined as successful placement of endotracheal tube within the trachea and

Secondary outcomes

  1. time to intubation

    Time frame: 10 minutes

    defined as time between insertion of the videolaryngoscope/ Macintosh blade into the mouth until detection of end-tidal CO2

  2. Laryngoscopic view

    Time frame: 10 minutes

    Cormack and Lehane Score

  3. Number of intubation attempts

    Time frame: 10 minutes

  4. Unrecognized esophageal intubation

    Time frame: 10 minutes

  5. Ease of intubation (1-5)

    Time frame: 10 minutes

    o (1) very easy, (2) easy, (3) somewhat difficult, (4) difficult, (5) impossible

  6. Violations of the teeth

    Time frame: 10 minutes

    number of patients; teeth will be inspected for potential damage and documented accordingly

  7. Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)

    Time frame: 10 minutes

    number of patients, requiring alternate device

  8. Maximum drop of saturation

    Time frame: 10 minutes

    Spo2 will be measured continuously and documented accordingly

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2014
Registry last updated
Mar 25, 2016

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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