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

• ClinicalTrials.gov Identifier: NCT04764799
• Recruitment Status: Recruiting
• First Posted: February 21, 2021
• Last Update Posted: December 6, 2021
• Sponsor: University Hospital Inselspital, Berne
• Information provided by (Responsible Party): Thomas Riva, University Hospital Inselspital, Berne

Study Description

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.

Condition or disease	Intervention/treatment
Respiratory Failure	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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Day
• Official Title: HEAVEN Criteria: a Monocentric Prospective Observational Study to Validate the Prediction of Difficult Airway for In-Hospital Emergency Airway Management
• Actual Study Start Date: December 1, 2021
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: August 2023

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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.

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

Contacts and Locations

Contacts

Contact: Thomas Riva, MD; +41 31 632 21 11; thomas.riva@insel.ch

Contact: Robert Greif, MD, Prof.; +41 31 632 21 11; robert.greif@insel.ch

Locations

Switzerland

University Hospital Bern; Recruiting

Bern, Switzerland, 3010

Contact: Thomas Riva, MD +41 31 632 21 11 thomas.riva@insel.ch

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

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

More Information

• Responsible Party: Thomas Riva, Principal Investigator, University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT04764799
• Other Study ID Numbers: HEAVEN_BRN; 2020-02458 ( Registry Identifier: swissethics )
• First Posted: February 21, 2021
• Last Update Posted: December 6, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Riva, University Hospital Inselspital, Berne:

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

Additional relevant MeSH terms:

Respiratory Insufficiency; Emergencies; Disease Attributes; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases