Clinical trial NCT04764799: HEAVEN Criteria: Prediction of Difficult Airway for In- Hospital Emergency Airway Management
Official title: HEAVEN Criteria: a Monocentric Prospective Observational Study to Validate the Prediction of Difficult Airway for In-Hospital Emergency Airway Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: Emergency Medicine
Intubation, Intratracheal
Anesthesiology
Rapid Sequence Induction
Difficult Airway
Prediction Tool
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 2800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients with first-attempt success rate of RSI
timeFrame: 1 hour
measure: Patients with difficulty of intubation
timeFrame: 1 hour
Secondary outcomes:
measure: Overall success rate of rapid sequence induction (RSI)
timeFrame: 1 hour
measure: Patients with first-attempt success without desaturation SpO2 <92% during RSI
timeFrame: 1 hour
measure: Total attempts of intubation in a patient
timeFrame: 1 hour
measure: Cormack & Lehane grade (C&L) or Percentage of Glottis Opening (POGO) in a patient
timeFrame: 1 hour
measure: Lowest and highest recorded value of patients' heart rate (HR) during RSI
timeFrame: 1 hour
measure: Lowest and highest recorded value of patients' blood-pressure (BP) during RSI
timeFrame: 1 hour
measure: Lowest and highest recorded value of patients' oxygen saturation (SpO2) during RSI
timeFrame: 1 hour
measure: Patients with use of vasoconstrictors during RSI
timeFrame: 1 hour
measure: Patients with use of devices/ techniques for intubation
timeFrame: 1 hour
measure: Patients with use and type of neuromuscular blockage agent
timeFrame: 1 hour
measure: Patient's demographics
timeFrame: 1 hour
measure: Type of planned procedure
timeFrame: 1 day
measure: Place of intubation
timeFrame: 1 day
measure: Time of intubation
timeFrame: 1 hour
measure: Level of airway manager
timeFrame: 1 hour
measure: Endotracheal tube (ETT)
timeFrame: 1 hour
measure: Patients with airway-related injuries like blood, damage to tissue, lips or teeth caused directly during intubation
timeFrame: 1 hour
measure: Patients with airway-related complains like hoarseness or problems with swallowing until 24 hours after intubation reported subjectively by the patient
timeFrame: 1 day
measure: Patients with suspicion of aspiration during RSI
timeFrame: 1 day
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Switzerland
name: Robert Greif, MD, Prof.
role: STUDY_CHAIR
References: