HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation

Recruiting

• Conditions: Intubation Complication; Intubation; Difficult or Failed

• Registration Number: NCT05954533
• Lead Sponsor: Jubilee Mission Medical College and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-06-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First attempt intubation success rate	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	Two hours	Physicians subjective assessment of airway as easy or difficult

Secondary Outcome Measures

Name	Time	Method
Total attempts of intubation.	Two hours	Total number of attempts is divided into less than 10 number of attempts, 10 to 100 and \>100attempts
Which criteria was the most frequent in causing difficult airway among HEAVEN	Two hours
Measuring if patient had hypotension	2 hours	SBP 100 and 20% decrease from baseline
Measuring if patient had hypertension	2 hours	SBP \>160 and 20% increase from baseline
Measurement of bradycardia	Two hours	Adults: HR \< 40bpm and 20% decrease from baseline Paeds \<12yrs: \<60beats/min requiring atropine

Trial Locations

Locations (1)

JMMCRI; 🇮🇳 Thrissur, Kerala, India