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NCT Number: NCT04764799

HEAVEN Criteria: 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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid sequence induction

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.

Primary outcomes

  1. Patients with first-attempt success rate of RSI

    Time frame: 1 hour

    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)

  2. Patients with difficulty of intubation

    Time frame: 1 hour

    Rated on a scale by the airway manager: easy, difficult, not possible

Secondary outcomes

  1. Overall success rate of rapid sequence induction (RSI)

    Time frame: 1 hour

    All RSI during the study period are analyzed for success (If intubation is possible or not)

  2. Patients with first-attempt success without desaturation SpO2 <92% during RSI

    Time frame: 1 hour

    Saturation will be measured and recorded during the whole intervention and analyzed for the time of the RSI.

  3. Total attempts of intubation in a patient

    Time frame: 1 hour

    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

  4. Cormack & Lehane grade (C&L) or Percentage of Glottis Opening (POGO) in a patient

    Time frame: 1 hour

    C&L for direct laryngoscopy or POGO for video laryngoscopy will be recorded for every intubation

  5. Lowest and highest recorded value of patients' heart rate (HR) during RSI

    Time frame: 1 hour

    Heart rate will be measured and recorded during the whole intervention and analyzed for the time of the RSI.

  6. Lowest and highest recorded value of patients' blood-pressure (BP) during RSI

    Time frame: 1 hour

    BP will be measured and recorded during the whole intervention and analyzed for the time of the RSI.

  7. Lowest and highest recorded value of patients' oxygen saturation (SpO2) during RSI

    Time frame: 1 hour

    SpO2 will be measured and recorded during the whole intervention and analyzed for the time of the RSI.

  8. Patients with use of vasoconstrictors during RSI

    Time frame: 1 hour

    Use of vasoconstrictors will be recorded during the whole intervention and analyzed for the time of the RSI.

  9. Patients with use of devices/ techniques for intubation

    Time frame: 1 hour

    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)

  10. Patients with use and type of neuromuscular blockage agent

    Time frame: 1 hour

    Yes / No, if Yes, specify: Succinylcholine, Rocuronium, Atracurium, other

  11. Patient's demographics

    Time frame: 1 hour

    Patient's age, gender, weight and size

  12. Type of planned procedure

    Time frame: 1 day

    type of surgery by discipline (e.g. ear, nose and throat (ENT), visceral, orthopedic, heart, urology, gynecology) and specification (e.g. appendectomy)

  13. Place of intubation

    Time frame: 1 day

    The place where the intubation is performed. Either operation room (OR) or outside OR

  14. Time of intubation

    Time frame: 1 hour

    the exact time (HH:MM:SS) in central european time of the induction of the RSI

  15. Level of airway manager

    Time frame: 1 hour

    nurse, resident or attending anaesthesiologist

  16. Endotracheal tube (ETT)

    Time frame: 1 hour

    Type and size of the used ETT(s) during the RSI attempt(s)

  17. Patients with airway-related injuries like blood, damage to tissue, lips or teeth caused directly during intubation

    Time frame: 1 hour

    Will be directly recorded if occurred during the RSI by the airway manager or team

  18. Patients with airway-related complains like hoarseness or problems with swallowing until 24 hours after intubation reported subjectively by the patient

    Time frame: 1 day

    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

  19. Patients with suspicion of aspiration during RSI

    Time frame: 1 day

    Newly recorded suspicion of aspiration during intubation will be recorded by the airway team

Sponsors and collaborators

Lead sponsor

Thomas Riva

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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