Respiratory FailureNCT04764799
HEAVEN Criteria: Prediction of Difficult Airway for In- Hospital Emergency Airway Management
An observational study of Respiratory Failure, run by Thomas Riva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Rapid sequence induction
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 2,800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2021to 31 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients without informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HEAVEN Criteria: a Monocentric Prospective Observational Study to Validate the 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.
Read the 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.
- Conditions
- Respiratory Failure
- Being tested
- Rapid sequence induction
- Keywords
- Emergency Medicine, Intubation, Intratracheal, Anesthesiology, Rapid Sequence Induction, Difficult Airway, Prediction Tool
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid sequence inductionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Rapid sequence induction | |
| 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. Receives: Procedure: Rapid sequence induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour
Patients with difficulty of intubation
Rated on a scale by the airway manager: easy, difficult, not possible
Measured: 1 hour
Secondary outcomes (19)
Overall success rate of rapid sequence induction (RSI)
All RSI during the study period are analyzed for success (If intubation is possible or not)
Measured: 1 hour
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.
Measured: 1 hour
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
Measured: 1 hour
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
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
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)
Measured: 1 hour
Patients with use and type of neuromuscular blockage agent
Yes / No, if Yes, specify: Succinylcholine, Rocuronium, Atracurium, other
Measured: 1 hour
Patient's demographics
Patient's age, gender, weight and size
Measured: 1 hour
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)
Measured: 1 day
Place of intubation
The place where the intubation is performed. Either operation room (OR) or outside OR
Measured: 1 day
Time of intubation
the exact time (HH:MM:SS) in central european time of the induction of the RSI
Measured: 1 hour
Level of airway manager
nurse, resident or attending anaesthesiologist
Measured: 1 hour
Endotracheal tube (ETT)
Type and size of the used ETT(s) during the RSI attempt(s)
Measured: 1 hour
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
Measured: 1 hour
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
Measured: 1 day
Patients with suspicion of aspiration during RSI
Newly recorded suspicion of aspiration during intubation will be recorded by the airway team
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Dec 2021
- Primary completion30 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,800 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Thomas Riva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Riva, Insel Gruppe AG, University Hospital Bern
- Investigators
- Robert Greif, MD, Prof., Study chair, Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764799
- Sponsor's protocol ID
- HEAVEN_BRN
- Other IDs
- 2020-02458
- Status last verified
- May 2024
- First submitted
- 18 Feb 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEAVEN Criteria: a Monocentric Prospective Observational Study to Validate the Prediction of Difficult Airway for In-Hospital Emergency Airway Management
- ClinicalTrials.gov ID
- NCT04764799
- Acronym / sponsor ID
- HEAVEN_BRN
- Conditions
- Respiratory Failure
- Keywords
- Emergency Medicine, Intubation, Intratracheal, Anesthesiology, Rapid Sequence Induction, Difficult Airway, Prediction Tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (actual)
- Lead sponsor
- Thomas RivaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients that need emergency rapid sequence inductions | – | Procedure: Rapid sequence inductionPatients 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 | – | Procedure: Rapid sequence inductionPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients without informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid sequence inductionRapid 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. | Procedure or surgery | Patients that need emergency rapid sequence inductions, Patients that need scheduled rapid sequence inductions |
Primary outcome
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)
Patients with difficulty of intubation
Time frame: 1 hour
Rated on a scale by the airway manager: easy, difficult, not possible
19 secondary outcomes
Overall success rate of rapid sequence induction (RSI)
Time frame: 1 hour
Patients with first-attempt success without desaturation SpO2 <92% during RSI
Time frame: 1 hour
Total attempts of intubation in a patient
Time frame: 1 hour
Cormack & Lehane grade (C&L) or Percentage of Glottis Opening (POGO) in a patient
Time frame: 1 hour
Lowest and highest recorded value of patients' heart rate (HR) during RSI
Time frame: 1 hour
Lowest and highest recorded value of patients' blood-pressure (BP) during RSI
Time frame: 1 hour
Lowest and highest recorded value of patients' oxygen saturation (SpO2) during RSI
Time frame: 1 hour
Patients with use of vasoconstrictors during RSI
Time frame: 1 hour
Patients with use of devices/ techniques for intubation
Time frame: 1 hour
Patients with use and type of neuromuscular blockage agent
Time frame: 1 hour
Patient's demographics
Time frame: 1 hour
Type of planned procedure
Time frame: 1 day
Place of intubation
Time frame: 1 day
Time of intubation
Time frame: 1 hour
Level of airway manager
Time frame: 1 hour
Endotracheal tube (ETT)
Time frame: 1 hour
Patients with airway-related injuries like blood, damage to tissue, lips or teeth caused directly during intubation
Time frame: 1 hour
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
Patients with suspicion of aspiration during RSI
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Greif, MD, Prof. study chair
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Thomas Riva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with first-attempt success rate of RSI (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.