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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04764799
Enrollment
2800
Registered
2021-02-21
Start date
2021-12-01
Completion date
2023-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

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

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.

Interventions

PROCEDURERapid 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.

Sponsors

Thomas Riva
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patients with first-attempt success rate of RSI1 hourEvery 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)
Patients with difficulty of intubation1 hourRated on a scale by the airway manager: easy, difficult, not possible

Secondary

MeasureTime frameDescription
Total attempts of intubation in a patient1 hourEvery 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
Cormack & Lehane grade (C&L) or Percentage of Glottis Opening (POGO) in a patient1 hourC&L for direct laryngoscopy or POGO for video laryngoscopy will be recorded for every intubation
Lowest and highest recorded value of patients' heart rate (HR) during RSI1 hourHeart rate will be measured and recorded during the whole intervention and analyzed for the time of the RSI.
Lowest and highest recorded value of patients' blood-pressure (BP) during RSI1 hourBP will be measured and recorded during the whole intervention and analyzed for the time of the RSI.
Lowest and highest recorded value of patients' oxygen saturation (SpO2) during RSI1 hourSpO2 will be measured and recorded during the whole intervention and analyzed for the time of the RSI.
Patients with use of vasoconstrictors during RSI1 hourUse of vasoconstrictors will be recorded during the whole intervention and analyzed for the time of the RSI.
Patients with use of devices/ techniques for intubation1 hourUse 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)
Patients with use and type of neuromuscular blockage agent1 hourYes / No, if Yes, specify: Succinylcholine, Rocuronium, Atracurium, other
Overall success rate of rapid sequence induction (RSI)1 hourAll RSI during the study period are analyzed for success (If intubation is possible or not)
Type of planned procedure1 daytype of surgery by discipline (e.g. ear, nose and throat (ENT), visceral, orthopedic, heart, urology, gynecology) and specification (e.g. appendectomy)
Place of intubation1 dayThe place where the intubation is performed. Either operation room (OR) or outside OR
Time of intubation1 hourthe exact time (HH:MM:SS) in central european time of the induction of the RSI
Level of airway manager1 hournurse, resident or attending anaesthesiologist
Endotracheal tube (ETT)1 hourType and size of the used ETT(s) during the RSI attempt(s)
Patients with airway-related injuries like blood, damage to tissue, lips or teeth caused directly during intubation1 hourWill be directly recorded if occurred during the RSI by the airway manager or team
Patients with airway-related complains like hoarseness or problems with swallowing until 24 hours after intubation reported subjectively by the patient1 dayAll 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
Patients with suspicion of aspiration during RSI1 dayNewly recorded suspicion of aspiration during intubation will be recorded by the airway team
Patient's demographics1 hourPatient's age, gender, weight and size
Patients with first-attempt success without desaturation SpO2 <92% during RSI1 hourSaturation will be measured and recorded during the whole intervention and analyzed for the time of the RSI.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026