An observational study in Intubation; Difficult or Failed and Intubation Complication, sponsored by Jubilee Mission Medical College and Research Institute. Recruiting at 1 site in India. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Jubilee Mission Medical College and Research Institute · Observational
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.
Jubilee Mission Medical College and Research Institute is the lead sponsor of 25 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients from all age groups requiring endotracheal intubation and who gives consent for the study would be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Time frame: Two hours
Physicians assessment of intubation as easy or difficult
Physicians subjective assessment of airway as easy or difficult
Time frame: Two hours
Total attempts of intubation.
Total number of attempts is divided into less than 10 number of attempts, 10 to 100 and \>100attempts
Time frame: Two hours
Which criteria was the most frequent in causing difficult airway among HEAVEN
Time frame: Two hours
Measuring if patient had hypotension
SBP 100 and 20% decrease from baseline
Time frame: 2 hours
Measuring if patient had hypertension
SBP \>160 and 20% increase from baseline
Time frame: 2 hours
Measurement of bradycardia
Adults: HR \< 40bpm and 20% decrease from baseline Paeds \<12yrs: \<60beats/min requiring atropine
Time frame: Two hours
Started Jul 2022 (actual). Primary completion is estimated for Jun 2024, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jubilee Mission Medical College and Research Institute