HEAVEN Criteria: Prediction of Difficult Airway for In- Hospital Emergency Airway Management
- Conditions
- Respiratory Failure
- Interventions
- Procedure: Rapid sequence induction
- Registration Number
- NCT04764799
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2800
- 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
• Patients without informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients that need emergency rapid sequence inductions Rapid sequence induction 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. Patients that need scheduled rapid sequence inductions Rapid sequence induction 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.
- Primary Outcome Measures
Name Time Method Patients with difficulty of intubation 1 hour Rated on a scale by the airway manager: easy, difficult, not possible
Patients with first-attempt success rate of RSI 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)
- Secondary Outcome Measures
Name Time Method Patients with use of vasoconstrictors during RSI 1 hour Use of vasoconstrictors will be recorded during the whole intervention and analyzed for the time of the RSI.
Patients with first-attempt success without desaturation SpO2 <92% during RSI 1 hour Saturation 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 RSI 1 hour BP will be measured and recorded during the whole intervention and analyzed for the time of the RSI.
Patients with use of devices/ techniques for intubation 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)Endotracheal tube (ETT) 1 hour Type and size of the used ETT(s) during the RSI attempt(s)
Lowest and highest recorded value of patients' heart rate (HR) during RSI 1 hour Heart rate will be measured and recorded during the whole intervention and analyzed for the time of the RSI.
Overall success rate of rapid sequence induction (RSI) 1 hour All RSI during the study period are analyzed for success (If intubation is possible or not)
Lowest and highest recorded value of patients' oxygen saturation (SpO2) during RSI 1 hour SpO2 will be measured and recorded during the whole intervention and analyzed for the time of the RSI.
Patients with use and type of neuromuscular blockage agent 1 hour Yes / No, if Yes, specify: Succinylcholine, Rocuronium, Atracurium, other
Type of planned procedure 1 day type of surgery by discipline (e.g. ear, nose and throat (ENT), visceral, orthopedic, heart, urology, gynecology) and specification (e.g. appendectomy)
Place of intubation 1 day The place where the intubation is performed. Either operation room (OR) or outside OR
Level of airway manager 1 hour nurse, resident or attending anaesthesiologist
Patients with suspicion of aspiration during RSI 1 day Newly recorded suspicion of aspiration during intubation will be recorded by the airway team
Total attempts of intubation in a patient 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
Cormack & Lehane grade (C&L) or Percentage of Glottis Opening (POGO) in a patient 1 hour C\&L for direct laryngoscopy or POGO for video laryngoscopy will be recorded for every intubation
Patient's demographics 1 hour Patient's age, gender, weight and size
Time of intubation 1 hour the exact time (HH:MM:SS) in central european time of the induction of the RSI
Patients with airway-related injuries like blood, damage to tissue, lips or teeth caused directly during intubation 1 hour Will 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 patient 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
Trial Locations
- Locations (1)
University Hospital Bern
🇨🇭Bern, Switzerland