NCT04364633

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Intubation Complication

Interventions

Type	Name	Description
OTHER	Voice Handicap Questionnaire (VHI)	Voice Handicap Index (VHI) self-questionnaire

Timeline

• Start date: 2020-06-16
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-04-28
• Last updated: 2022-04-19

Locations

1 site across 1 country: France