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

HEAVEN Criteria: a Monocentric Prospective Observational Study to Validate the Prediction of Difficult Airway for In-Hospital Emergency Airway Management

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: Rapid sequence induction

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.

• Study Type: Observational
• Enrollment (Actual): 2800

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall success rate of rapid sequence induction (RSI)	All RSI during the study period are analyzed for success (If intubation is possible or not)	1 hour
Patients with first-attempt success without desaturation SpO2 <92% during RSI	Saturation will be measured and recorded during the whole intervention and analyzed for the time of the RSI.	1 hour
Total attempts of intubation in a patient	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 CO2	1 hour
Cormack & Lehane grade (C&L) or Percentage of Glottis Opening (POGO) in a patient	C&L for direct laryngoscopy or POGO for video laryngoscopy will be recorded for every intubation	1 hour
Lowest and highest recorded value of patients' heart rate (HR) during RSI	Heart rate will be measured and recorded during the whole intervention and analyzed for the time of the RSI.	1 hour
Lowest and highest recorded value of patients' blood-pressure (BP) during RSI	BP will be measured and recorded during the whole intervention and analyzed for the time of the RSI.	1 hour
Lowest and highest recorded value of patients' oxygen saturation (SpO2) during RSI	SpO2 will be measured and recorded during the whole intervention and analyzed for the time of the RSI.	1 hour
Patients with use of vasoconstrictors during RSI	Use of vasoconstrictors will be recorded during the whole intervention and analyzed for the time of the RSI.	1 hour
Patients with use of devices/ techniques for intubation	Use of: supraglottic airway device (SAD); intubation guides (Frova, S-Guide); video laryngoscopy (VL) or direct laryngoscopy, shape and size of the blade, flexible scope; rigid stylets ("C-MAC VS", "Bonfils"); intubation over SAD; emergency front of neck access (eFONA)	1 hour
Patients with use and type of neuromuscular blockage agent	Yes / No, if Yes, specify: Succinylcholine, Rocuronium, Atracurium, other	1 hour
Patient's demographics	Patient's age, gender, weight and size	1 hour
Type of planned procedure	type of surgery by discipline (e.g. ear, nose and throat (ENT), visceral, orthopedic, heart, urology, gynecology) and specification (e.g. appendectomy)	1 day
Place of intubation	The place where the intubation is performed. Either operation room (OR) or outside OR	1 day
Time of intubation	the exact time (HH:MM:SS) in central european time of the induction of the RSI	1 hour
Level of airway manager	nurse, resident or attending anaesthesiologist	1 hour
Endotracheal tube (ETT)	Type and size of the used ETT(s) during the RSI attempt(s)	1 hour
Patients with airway-related injuries like blood, damage to tissue, lips or teeth caused directly during intubation	Will be directly recorded if occurred during the RSI by the airway manager or team	1 hour
Patients with airway-related complains like hoarseness or problems with swallowing until 24 hours after intubation reported subjectively by the patient	All patients will be visited in the first 24 hours after anaesthesia if they report subjectively airway-related complains like hoarseness or problems with swallowing until 24 hours after intubation and evaluated by an anaesthesiologist or further referred to an ENT specialist	1 day
Patients with suspicion of aspiration during RSI	Newly recorded suspicion of aspiration during intubation will be recorded by the airway team	1 day

Collaborators and Investigators

• Sponsor: Thomas Riva
• Investigators: Study Chair: Robert Greif, MD, Prof., Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Medicine; Difficult Airway; Anesthesiology; Intubation, Intratracheal; Rapid Sequence Induction; Prediction Tool
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Emergencies; Respiratory Insufficiency
• Other Study ID Numbers: HEAVEN_BRN; 2020-02458 (Registry Identifier: swissethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No