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HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05954533
Enrollment
192
Registered
2023-07-20
Start date
2022-07-01
Completion date
2024-07-01
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication, Intubation; Difficult or Failed

Keywords

HEAVEN criteria, Modified LEMON, Difficult airway, Prediction tool

Brief 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 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.

Interventions

None listed

Sponsors

Jubilee Mission Medical College and Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients not consenting for the study or · Patients in cardio respiratory arrest

Design outcomes

Primary

MeasureTime frameDescription
First attempt intubation success rateTwo hoursFirst 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 difficultTwo hoursPhysicians subjective assessment of airway as easy or difficult

Secondary

MeasureTime frameDescription
Measuring if patient had hypotension2 hoursSBP 100 and 20% decrease from baseline
Total attempts of intubation.Two hoursTotal number of attempts is divided into less than 10 number of attempts, 10 to 100 and \>100attempts
Measurement of bradycardiaTwo hoursAdults: HR \< 40bpm and 20% decrease from baseline Paeds \<12yrs: \<60beats/min requiring atropine
Measuring if patient had hypertension2 hoursSBP \>160 and 20% increase from baseline
Which criteria was the most frequent in causing difficult airway among HEAVENTwo hours

Countries

India

Contacts

Primary ContactJAISMOL JAMES, MBBS
jaismoljames.16@gmail.com91 9496660433
Backup ContactDr. APPU SUSEEL, MBBS, MD
appuariyedath@gmail.com91 9847749706

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026