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

NCT ID: NCT04764799

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Rapid sequence induction

Intervention Type 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 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.

Rapid sequence induction

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rapid sequence induction

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thomas Riva

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas Riva

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Greif, MD, Prof.

Role: STUDY_CHAIR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Bern

Bern, Canton of Bern, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-02458

Identifier Type: REGISTRY

Identifier Source: secondary_id

HEAVEN_BRN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.