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

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 Overview

• Status: Recruiting
• Conditions: Intubation Complication; Intubation; Difficult or Failed

• Study Type: Observational
• Enrollment (Estimated): 192

Contacts and Locations

• Study Contact: Name: JAISMOL JAMES, MBBS; Phone Number: 91 9496660433; Email: jaismoljames.16@gmail.com
• Study Contact Backup: Name: Dr. APPU SUSEEL, MBBS, MD; Phone Number: 91 9847749706; Email: appuariyedath@gmail.com

Study Locations

• India
  • Kerala
    • Thrissur, Kerala, India, 680005
      • Recruiting
      • JMMCRI
      • Contact: DR APPU SUSEEL, MBBS,MD; Phone Number: 9847749706; Email: appuariyedath@gmail.com
      • Contact: DR SIJU V ABRAHAM, MBBS,MD; Phone Number: 9447754321; Email: sijuvabraham@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Physicians assessment of intubation as easy or difficult	Physicians subjective assessment of airway as easy or difficult	Two hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jubilee Mission Medical College and Research Institute
• Investigators: Study Director: DR APPU SUSEEL, MBBS,MD, JMMCRI; Study Director: DR SIJU V ABRAHAM, MBBS,MD, JMMCRI

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Difficult airway; Prediction tool; HEAVEN criteria; Modified LEMON
• Other Study ID Numbers: 39/22/IEC/JMMC&RI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No