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HEAVEN Criteria: Prediction of Difficult Airway for In- Hospital Emergency Airway Management

T

Thomas Riva

Status

Completed

Conditions

Respiratory Failure

Treatments

Procedure: Rapid sequence induction

Study type

Observational

Funder types

Other

Identifiers

NCT04764799
2020-02458 (Registry Identifier)
HEAVEN_BRN

Details and patient eligibility

About

The HEAVEN criteria were found valid to predict difficult airways during preclinical emergency intubations in a retrospective study. The acronym stands for Hypoxemia, Extremes of size, Anatomic abnormalities, Vomit/blood/fluid, Exsanguination/anaemia, and Neck mobility issues. This is a monocentric prospective observational study to assess the validity of the HEAVEN criteria in the in-hospital setting at a level I adult and pediatric emergency university-based hospital.

Full description

Emergency intubations are prone to present a difficult airway. A difficult airway can lead to prolonged intubation time and to hypoxemia in situations where oxygenation is not possible that can finally result in hypoxic cardiac arrest and irreversible brain damage caused by hypoxic ischemic encephalopathy.

Tools to predict difficult airways are rather poor concerning specificity and sensitivity. A score to predict difficult airway developed in the pre-clinical setting are the HEAVEN criteria. The acronym HEAVEN stands for: Hypoxemia, Extremes of size, Anatomic abnormalities, Vomit/blood/fluid, Exsanguination/anaemia, and Neck mobility issues and does not need patients' cooperation. It has been recently validated in the pre-clinical emergency setting and was found to be useful.

The study aim is to evaluate if the HEAVEN criteria are suitable to be used to predict difficult airway in in-hospital emergency intubation to finally increase patients' safety during rapid sequence induction (RSI).

This prospective observational single-centre study in emergency intubation will consecutively recruit all patients of all ages who need RSI due to their medical condition performed by the staff of the Department of Anaesthesiology and Pain Medicine at the Bern University Hospital. We will record data that are gathered during routine patient care and stored primarily in the departmental anaesthesia information systems.

The primary objective is to validate if the HEAVEN criteria, an existing prehospital difficult airway prediction tool, is able to predict airways difficulties during RSI in the clinical in-hospital setting. The secondary objective is, to assess the subcomponent of the HEAVEN criteria and if differences and adaptations are needed comparing it to the prehospital setting.

Enrollment

2,800 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All consecutive patients of all ages who need an in-hospital rapid sequence intubation (RSI) performed by the staff of the Department of Anesthesiology and Pain Medicine
  • Given general consent or delayed obtained general consent after the procedure
  • English, German or French speaking patients

Exclusion criteria

• Patients without informed consent

Trial design

2,800 participants in 2 patient groups

Patients that need emergency rapid sequence inductions
Description:
Patients of all ages who need emergency rapid sequence inductions due to their medical condition performed by the staff of the Department of Anaesthesiology and Pain Medicine at the Bern University Hospital. We defined "emergency" as a non scheduled intervention with immediate (or maximum up to 6 hours after announcement) need of general anaesthesia (e.g. trauma patients with need for emergency surgery) and therefore appropriate fastening is not possible.
Treatment:
Procedure: Rapid sequence induction
Patients that need scheduled rapid sequence inductions
Description:
Patients of all ages who need scheduled rapid sequence inductions due to their medical condition performed by the staff of the Department of Anaesthesiology and Pain Medicine at the Bern University Hospital. Patients of this cohort have a scheduled intervention and therefore can fasten meals for at least 6 hours before induction of general anaesthesia.
Treatment:
Procedure: Rapid sequence induction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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