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

Intubation Complication Clinical Trial

— VHIntubation  

Official title:

Study of the Impact of a Intra-tracheal Intubation With Curarization or Without Curarization (With Remifentanil) on the Self-perception of the Voice.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04364633
• Other study ID #: RC20_0058
• Status: Terminated
• Start date: June 16, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Some surgeries are known to expose patients to voice disorders (thyroidectomy, parathyroidectomy, carotid surgery…). However, voice disorders can be due, among other things, to a laryngeal nerves alteration and intubation trauma. Our team has published 2 prospective studies on the frequency of voice troubles after thyroidectomy (Borel et al. Surgery 2018 and 2019).

To limit post tracheal intubation voice troubles , it is generally recommended to practice intra-tracheal intubation with a curarization (Lundstrøm et al. Br J Anaesth 2018). However, for few years, the very vast majority of thyroid surgery is practiced with a neuromonitoring of laryngeal nerves (NIM). NIM ensures prosper functioning of the vocal cords intra- and post-operatively with an excellent negative predictive value (>98%, Mirallié et al. Surgery 2018). However, the use of NIM requires an absence of curarization. Some centres, including ours, have abandoned systematic curarization before intubation for thyroidectomy; other centres continue to practice curarization with, sometimes, the need to antagonize curarization for an effective NIM utilization.

The aim of this study is to assess the impact of intubation preparation procedures (curarization versus remifentanil) on the voice using Voice Handicap Index (VHI) questionnaire.

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 ", the coordinator of which is Dr Nicolas Grillot.

This study began in October 2019 and authorisations are obtained. We aim to propose our study " VHIntubation " to patients participating in REMICRUSH in order to benefit from REMIFENTANIL versus CURARE randomization.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 induction

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Other:
• Voice Handicap Questionnaire (VHI)
Voice Handicap Index (VHI) self-questionnaire

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Voice Handicap at 6 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 6 month post-intubation.; Primary endpoint is the evolution of the score at VHI questionnaire (Voice Handicap Index) at 6 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).	6 month post-intubation