Intubation; Difficult or FailedNCT05954533
HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation
An observational study of Intubation; Difficult or Failed and Intubation Complication, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial summary
Emergency tracheal intubation is a lifesaving procedure frequently performed on critically ill and injured patients in the emergency department (ED). Emergency intubations are more difficult than elective intubations in the operating room setting because of the sicker patient population with a limited physiologic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication
- How many people
- 192 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2022to 1 Jul 2024
- 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 from all age groups requiring endotracheal intubation and who gives consent for the study would be included.
Who may be able to join
- 1. All patients who undergo an endotracheal intubation in the emergency medicine department and 2. who legally give consent for the study or relatives give consent
Who cannot join
- Patients not consenting for the study or · Patients in cardio respiratory arrest
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
JMMCRI
Thrissur, Kerala, 680005
DR APPU SUSEEL, MBBS,MD, 9847749706, appuariyedath@gmail.com
DR SIJU V ABRAHAM, MBBS,MD, 9447754321, sijuvabraham@gmail.com
About this study
Official title: Cross Sectional Study to Determine Whether HEAVEN CRITERIA is a Better Tool Than Modified LEMON Score for Predicting Difficult Intubation in In-hospital Emergency Airway Management
Emergency tracheal intubation is a lifesaving procedure frequently performed on critically ill and injured patients in the emergency department (ED). Emergency intubations are more difficult than elective intubations in the operating room setting because of the sicker patient population with a limited physiologic reserve and less controlled setting in the ED. Indeed, the proportion of difficult intubation ranges from 10% to 27% in the ED setting , whereas the rate ranges from 1% to 9% of elective intubation in the anaesthesia setting. Because emerging evidence demonstrates that repeated intubation attempts are associated with an increased risk of adverse events, early recognition of difficulty intubation with a systematic use of rescue methods in ED patients is critical. The commonest airway prediction tool is the LEMON score. In the modified LEMON score "Mallampati" was excluded as it was not a pragmatic assessment in the ED.
Existing difficult airway prediction tools were derived in the elective surgery environment and may not be applicable to emergency airway management. LEMON criteria was designed for preoperative clinical setting.
Hence in this study we are observing if HEAVEN (H- Hypoxemia E - extremes of age A - anatomical abnormalities V - vomit/ blood / fluid E - Exsanguination/anaemia N - neck mobility issues) is a better tool for predicting difficult intubatio.
- Keywords
- HEAVEN criteria, Modified LEMON, Difficult airway, Prediction tool
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt intubation success rate
First attempt success would be defined as the placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth
Measured: Two hours
Physicians assessment of intubation as easy or difficult
Physicians subjective assessment of airway as easy or difficult
Measured: Two hours
Secondary outcomes (5)
Total attempts of intubation.
Total number of attempts is divided into less than 10 number of attempts, 10 to 100 and >100attempts
Measured: Two hours
Which criteria was the most frequent in causing difficult airway among HEAVEN
Measured: Two hours
Measuring if patient had hypotension
SBP 100 and 20% decrease from baseline
Measured: 2 hours
Measuring if patient had hypertension
SBP >160 and 20% increase from baseline
Measured: 2 hours
Measurement of bradycardia
Adults: HR < 40bpm and 20% decrease from baseline Paeds <12yrs: <60beats/min requiring atropine
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Jul 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies 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
- Cross-sectional
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jaismol James, Jubilee Mission Medical College and Research Institute
- Investigators
- DR APPU SUSEEL, MBBS,MD, Study director, JMMCRIDR SIJU V ABRAHAM, MBBS,MD, Study director, JMMCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954533
- Sponsor's protocol ID
- 39/22/IEC/JMMC&RI
- Status last verified
- Mar 2024
- First submitted
- 13 Jul 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Study to Determine Whether HEAVEN CRITERIA is a Better Tool Than Modified LEMON Score for Predicting Difficult Intubation in In-hospital Emergency Airway Management
- ClinicalTrials.gov ID
- NCT05954533
- Acronym / sponsor ID
- 39/22/IEC/JMMC&RI
- Keywords
- HEAVEN criteria, Modified LEMON, Difficult airway, Prediction tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 20 Jul 2023 (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.
Emergency tracheal intubation is a lifesaving procedure frequently performed on critically ill and injured patients in the emergency department (ED). Emergency intubations are more difficult than elective intubations in the operating room setting because of the sicker patient population with a limited physiologic reserve and less controlled setting in the ED. Indeed, the proportion of difficult intubation ranges from 10% to 27% in the ED setting , whereas the rate ranges from 1% to 9% of elective intubation in the anaesthesia setting. Because emerging evidence demonstrates that repeated intubation attempts are associated with an increased risk of adverse events, early recognition of difficulty intubation with a systematic use of rescue methods in ED patients is critical. The commonest airway prediction tool is the LEMON score. In the modified LEMON score "Mallampati" was excluded as it was not a pragmatic assessment in the ED.
Existing difficult airway prediction tools were derived in the elective surgery environment and may not be applicable to emergency airway management. LEMON criteria was designed for preoperative clinical setting.
Hence in this study we are observing if HEAVEN (H- Hypoxemia E - extremes of age A - anatomical abnormalities V - vomit/ blood / fluid E - Exsanguination/anaemia N - neck mobility issues) is a better tool for predicting difficult intubatio.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from all age groups requiring endotracheal intubation and who gives consent for the study would be included.
Key inclusion criteria (1 listed)
- 1. All patients who undergo an endotracheal intubation in the emergency medicine department and 2. who legally give consent for the study or relatives give consent
Key exclusion criteria (1 listed)
- Patients not consenting for the study or · Patients in cardio respiratory arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
First attempt intubation success rate
Time frame: Two hours
First attempt success would be defined as the placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth
Physicians assessment of intubation as easy or difficult
Time frame: Two hours
Physicians subjective assessment of airway as easy or difficult
5 secondary outcomes
Total attempts of intubation.
Time frame: Two hours
Which criteria was the most frequent in causing difficult airway among HEAVEN
Time frame: Two hours
Measuring if patient had hypotension
Time frame: 2 hours
Measuring if patient had hypertension
Time frame: 2 hours
Measurement of bradycardia
Time frame: Two hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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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.
DR APPU SUSEEL, MBBS,MD study director
JMMCRI
DR SIJU V ABRAHAM, MBBS,MD study director
JMMCRI
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 Intubation; Difficult or Failed and Intubation Complication, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JAISMOL JAMES, MBBS (91 9496660433, jaismoljames.16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt intubation success rate (time frame: Two hours). 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 8 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.