HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation

NCT05954533 | Recruiting

• 1 other identifier: 39/22/IEC/JMMC&RI
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed; Intubation Complication

Keywords

HEAVEN criteria; Modified LEMON; Difficult airway; Prediction tool

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Total attempts of intubation.

  Two hours

• Which criteria was the most frequent in causing difficult airway among HEAVEN

  Two hours

• Measuring if patient had hypotension

  2 hours

• Measuring if patient had hypertension

  2 hours

• Measurement of bradycardia

  Two hours

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

JMMCRI

Thrissur, Kerala, 680005, India

RECRUITING

Study Officials

• DR APPU SUSEEL, MBBS,MD

  JMMCRI

  STUDY DIRECTOR

• DR SIJU V ABRAHAM, MBBS,MD

  JMMCRI

  STUDY DIRECTOR

Central Study Contacts

JAISMOL JAMES, MBBS

CONTACT

91 9496660433; jaismoljames.16@gmail.com

Dr. APPU SUSEEL, MBBS, MD

CONTACT

91 9847749706; appuariyedath@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 20, 2023
• Study Start: July 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

IN (1)