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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764799
• Other study ID #: HEAVEN_BRN
• Secondary ID: 2020-02458
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2800
• Est. completion date: December 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patients with difficulty of intubation	Rated on a scale by the airway manager: easy, difficult, not possible	1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patients with use and type of neuromuscular blockage agent	Yes / No, if Yes, specify: Succinylcholine, Rocuronium, Atracurium, other	1 hour
Secondary	Patient's demographics	Patient's age, gender, weight and size	1 hour
Secondary	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
Secondary	Place of intubation	The place where the intubation is performed. Either operation room (OR) or outside OR	1 day
Secondary	Time of intubation	the exact time (HH:MM:SS) in central european time of the induction of the RSI	1 hour
Secondary	Level of airway manager	nurse, resident or attending anaesthesiologist	1 hour
Secondary	Endotracheal tube (ETT)	Type and size of the used ETT(s) during the RSI attempt(s)	1 hour
Secondary	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
Secondary	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
Secondary	Patients with suspicion of aspiration during RSI	Newly recorded suspicion of aspiration during intubation will be recorded by the airway team	1 day