Clinical trial NCT05954533: HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intubation; Difficult or Failed
Intubation Complication
Keywords: HEAVEN criteria
Modified LEMON
Difficult airway
Prediction tool
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from all age groups requiring endotracheal intubation and who gives consent for the study would be included.

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.


Eligibility criteria: 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

Primary outcomes:
measure: First attempt intubation success rate
timeFrame: Two hours
measure: Physicians assessment of intubation as easy or difficult
timeFrame: Two hours
Secondary outcomes:
measure: Total attempts of intubation.
timeFrame: Two hours
measure: Which criteria was the most frequent in causing difficult airway among HEAVEN
timeFrame: Two hours
measure: Measuring if patient had hypotension
timeFrame: 2 hours
measure: Measuring if patient had hypertension
timeFrame: 2 hours
measure: Measurement of bradycardia
timeFrame: Two hours
Other outcomes:
Locations:
city: Thrissur
country: India
facility: JMMCRI
state: Kerala
Study officials:
affiliation: JMMCRI
name: DR APPU SUSEEL, MBBS,MD
role: STUDY_DIRECTOR
affiliation: JMMCRI
name: DR SIJU V ABRAHAM, MBBS,MD
role: STUDY_DIRECTOR
References: