HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation

Intubation Complication Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954533
• Other study ID #: 39/22/IEC/JMMC&RI
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Jubilee Mission Medical College and Research Institute
• Contact: JAISMOL JAMES, MBBS
• Phone: 91 9496660433
• Email: jaismoljames.16[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication
• Intubation; Difficult or Failed

Locations

Country	Name	City	State
India	JMMCRI	Thrissur	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Jubilee Mission Medical College and Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Two hours
Primary	Physicians assessment of intubation as easy or difficult	Physicians subjective assessment of airway as easy or difficult	Two hours
Secondary	Total attempts of intubation.	Total number of attempts is divided into less than 10 number of attempts, 10 to 100 and >100attempts	Two hours
Secondary	Which criteria was the most frequent in causing difficult airway among HEAVEN		Two hours
Secondary	Measuring if patient had hypotension	SBP 100 and 20% decrease from baseline	2 hours
Secondary	Measuring if patient had hypertension	SBP >160 and 20% increase from baseline	2 hours
Secondary	Measurement of bradycardia	Adults: HR < 40bpm and 20% decrease from baseline Paeds <12yrs: <60beats/min requiring atropine	Two hours