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Completed

NCT Number: NCT03420027

Prehospital and Emergency Feasibility of MACOCHA Score Assessment to Predict Difficult Tracheal Intubation

A seven-item simplified score (the MACOCHA score) has been validated to predict difficult tracheal intubation in intensive care unit patients. In the prehospital or in the emergency department settings, no such validated predictive score is available yet. The aim of the present study is to assess the feasibility the quick calculation of the MACOCHA score before emergent intubation, in the prehospital and emergency department contexts.

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Key information

Conditions

Intubation, Intratracheal Emergency Medicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR d'Orléans

Orléans, 45067, France

About this study

All patients who will have to undergo emergent tracheal intubation for any reason in the prehospital context or at the emergency department at a single 1100-bed regional and teaching hospital in France, will be included in this observational, prospective study, provided that neither the patient him/herself, if capable, or next-of-kin if present have declined participation.

Items of the MACOCHA score will be recorded before intubation by investigators, who are all certified emergency physicians skilled with urgent tracheal intubation.

For any intubation procedure, either in the out-of-hospital context or in the Emergency Department, one of these emergency physicians is always present.

The feasibility the quick MACOCHA score calculation before urgent intubation will be assessed by the number and percentages of patients for whom all the seven items of the score have been collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient ≥ 18 yrs
  • Patient who have to undergo rapid sequence tracheal intubation as judged by the Emergency Physician

Exclusion criteria

  • Pregnancy
  • Cardiac arrest of any cause as the indication for intubation
  • Patient or next-of-kin declining participation

Treatment and study plan

questionnaire to be filled in by investigators

Other

A simple seven-item questionnaire will be filled in by the investigator before performing urgent tracheal intubation. This intubation, which will be performed as done in routine care, does not constitute a study specific intervention

Primary outcomes

  1. number of missing items of the MACOCHA score

    Time frame: 5 minutes

    The MACOCHA score is a predictive score of difficult intubation in intensive care to anticipate and prepare the appropriate equipment, possibly use an alternative strategy of intubation and call for help to reduce the risk of morbidity and mortality.

    The MACOCHA score involves various simple assessment items: a Mallampati III or IV, a sleep apnea syndrome, a decrease in cervical mobility, a mouth opening <3cm, a coma defined by a Glasgow score <8, severe hypoxemia, and if the practitioner is not anesthetist.

    Missing items are defined as those for which relevant information cannot be collected before intubation.

Secondary outcomes

  1. Adverse events

    Time frame: 30 min

    occurrence of any adverse event during and 30 minutes after intubation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Evaluation of the Feasibility of the MACOCHA Score and Indication of Endotracheal Intubation in Prehospital and Emergency Room: a Prospective Observational Study

Acronym: E-MAC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Jun 10, 2019

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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