Data patient
OtherMedical History and characteristic of patient
NCT Number: NCT05539391
This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
CHU d'Angers, Angers, France
Several studies have reported positive impact of some interventions on the tracheal intubation-related complications incidence. Providing bag face-mask ventilation between medication administration and initiation of laryngoscopy significantly reduced the number of peri intubation hypoxemia episodes. The use of a non-depolarizing (rocuronium) paralytic agent instead of succinylcholine is associated with less post-intubation complications occurrence. Finally, use of a tracheal tube introducer (GEB) as an aid for intubation in emergency patients with at least one prognostic factor of difficult laryngoscopy has been shown to facilitate intubation. Assessment of a strategy combining these three interventions to reduce intubation related morbidity in emergency situations has never been assessed. It is expected that the combination of these interventions will drastically reduce the morbidity associated with emergency intubation. The strategy assessed will associate rocuronium use as paralyzing agent to facilitate intubation, bag mask ventilation before intubation and GEB use at first intubation attempt in all patients. The emergency physician in charge of the patients will record out-of hospital outcomes immediately after the out-of-hospital period. Intra-hospital data will be retrieved from the patient's medical record on the 28th day after inclusion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medical History and characteristic of patient
Arterial pressure, arterial oxygen saturation, heart rate
Rapid sequence intubation (RSI) will be performed with use of rocuronium as paralytic agent (1.2 mg/ kg). Bag-mask ventilation between induction and laryngoscopy will be performed. The GEB will be systematically used at the first attempt to facilitate intubation.
Rapid sequence intubation (RSI) using succinylcholine as a paralytic agent (1 mg/kg), no systematic bag-mask ventilation between induction and laryngoscopy, use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy.
Time frame: Day 0
Proportion of patients with severe intubation-related complications occurring during the first hour after intubation
The severe intubation-related complications are:
Time frame: Day 0
Intubation Difficulty Score (IDS). minimum values is 0 and the maximum values is dependent on the added elements.
Time frame: Day 0
Intubation conditions assessed by the Copenhagen score - The value is clinically not acceptable and clinical acceptable
Time frame: Day 0
Proportion of patients intubated by alternative techniques.
Time frame: Day 0
Mean number of intubation attempts
Time frame: Day 0
Mean number of intubation failures under direct laryngoscopy.
Time frame: Day 0
Mean time of out-of-hospital care (in minutes)
Time frame: Day 0
Mean total amount of sedative drugs used after intubation
Time frame: Day 0
Mean total amount of vasopressors used after intubation
Time frame: Day 0
Out-of-hospital mortality.
Time frame: Day 28
Vital status
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial
Acronym: OSETIM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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