Impact of a Intra-tracheal Intubation With Curarization or Without Curarization

NCT04364633 | Terminated

• 1 other identifier: RC20_0058
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation Complication

Keywords

Intra-tracheal intubation; Voice Handicap; Remifentanil; Curarization

Outcome Measures

Primary Outcomes (1)

• Voice Handicap at 1 month post-intubation

  Evaluate the impact of the procedures to prepare at intra-tracheal intubation (curarization versus remifentanil) on the voice, using Voice Handicap Index (VHI) self-questionnaire at 1 month post-intubation. Primary endpoint is the evolution of the score at VHI questionnaire (Voice Handicap Index) at 1 month post-intubation, the reference is the pre-intubation score. An augmentation of 18 points score is considered as significant (Borel et al. Surgery 2018).

  1 month post-intubation

Secondary Outcomes (1)

• Voice Handicap at 6 month post-intubation

  6 month post-intubation

Study Arms (2)

Remifentanil group

bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction

Other: Voice Handicap Questionnaire (VHI)

Neuromuscular blockade group

Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction

Other: Voice Handicap Questionnaire (VHI)

Interventions

Voice Handicap Questionnaire (VHI) OTHER

Voice Handicap Index (VHI) self-questionnaire

Neuromuscular blockade group; Remifentanil group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Nantes University Hospital is the sponsor of " REMICRUSH ", study on " Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant. A Non-inferiority Simple Blind Randomized Controlled Trial ", We aim to propose our study " VHIntubation " to patients participating in REMICRUSH in order to benefit from REMIFENTANIL versus CURARE randomization.

You may qualify if:

• Patients included in " REMICRUSH " study
• patient's non-opposition to participation in research
• 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

You may not qualify if:

• Patients non-included in " REMICRUSH " study
• Patients with cervical surgery
• Patient declines to participate in research
• 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 induction

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: June 16, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 19, 2022

Record last verified: 2021-09

Locations

FR (1)