Impact of a Intra-tracheal Intubation With Curarization or Without Curarization (NCT04364633) | Clinical Trial Compass
TerminatedNot Applicable
Impact of a Intra-tracheal Intubation With Curarization or Without Curarization
Stopped: Premature termination of the study because it was dependent on the Remicrush study which ended more quickly, not allowing the inclusion of the expected number of patients.
France7 participantsStarted 2020-06-16
Plain-language summary
VHIntubation is a French monocentric and observational study that will assess the impact of two intra-tracheal intubation preparation procedures (curarization versus remifentanil) on the voice, using the Voice Handicap Index (VHI) self-questionnaire.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients included in " REMICRUSH " study
* patient's non-opposition to participation in research
Inclusions criteria in REMICRUSH are :
* male or female aged from 18 to 80 years old
* surgery requiring general anaesthesia with tracheal with oro-tracheal intubation
* Rapid sequence intubation indication
* aspiration risk defined as : fasting \< 6h00, digestive occlusion, functional ileus, vomiting \< 12h00, orthopaedic trauma \< 12h00, severe gastric reflux, gastroparesis and/or dysautonomia and or gastro-oesophagus surgery
* signed informed consent sheet ; or emergency procedure if impossible
Exclusion Criteria:
* Patients non-included in " REMICRUSH " study
* Patients with cervical surgery
* Patient declines to participate in research
Exclusion criteria in REMICRUSH are :
* planned impossible intubation
* suspected/known allergy to neuromuscular blockade or remifentanil
* neuromuscular disease forbidding neuromuscular blockade use
* Prolonged neuromuscular block former episode
* Malignant hyperthermia former episode
* Pre-operative respiratory failure (spO2\< 95%)
* Pre-operative hemodynamic failure (use of vasopressor) cardiac arrest
* A woman of childbearing age who has an active pregnancy and/or clinical signs suggestive of an active pregnancy and/or does not have a contraceptive or contraceptive method and has had unprotected sex within 15 days of the last menstrual period.
* Patients under justice protection
* Use of etomidate for anesthetic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.