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

NCT04764799 | Completed

• 2 other identifiers: HEAVEN_BRN2020-02458
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Failure

Keywords

Emergency Medicine; Intubation, Intratracheal; Anesthesiology; Rapid Sequence Induction; Difficult Airway; Prediction Tool

Outcome Measures

Primary Outcomes (2)

• Patients with first-attempt success rate of RSI

  Every attempt starts with the insertion of a laryngoscope blade over the lips and ends with a blocked tube in the trachea and measuring of carbon dioxide (CO2)

  1 hour

• Patients with difficulty of intubation

  Rated on a scale by the airway manager: easy, difficult, not possible

  1 hour

Secondary Outcomes (19)

• Overall success rate of rapid sequence induction (RSI)

  1 hour

• Patients with first-attempt success without desaturation SpO2 <92% during RSI

  1 hour

• Total attempts of intubation in a patient

  1 hour

• Cormack & Lehane grade (C&L) or Percentage of Glottis Opening (POGO) in a patient

  1 hour

• Lowest and highest recorded value of patients' heart rate (HR) during RSI

  1 hour

Study Arms (2)

Patients that need emergency rapid sequence inductions

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.

Procedure: Rapid sequence induction

Patients that need scheduled rapid sequence inductions

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.

Procedure: Rapid sequence induction

Interventions

Rapid sequence induction PROCEDURE

Rapid sequence induction starts with the administration of rapid acting intravenous narcotics, opioids and neuromuscular blockage and avoids whenever possible positive-pressure ventilation after induction of anesthesia.

Patients that need emergency rapid sequence inductions; Patients that need scheduled rapid sequence inductions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who need rapid sequence intubation due to their medical condition at the Bern University Hospital are screened if they fulfill the inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• Patients without informed consent

Sponsors & Collaborators

• Thomas Riva: lead

Study Sites (1)

University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Rapid Sequence Induction and Intubation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Robert Greif, MD, Prof.

  Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: December 1, 2021
• Primary Completion: July 30, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)