Intubation ComplicationVHIntubationNCT04364633
Impact of a Intra-tracheal Intubation With Curarization or Without Curarization
An observational study of Intubation Complication, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Voice Handicap Questionnaire (VHI)
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Voice Handicap Questionnaire (VHI)
- Keywords
- Intra-tracheal intubation, Voice Handicap, Remifentanil, Curarization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice Handicap Questionnaire (VHI)Other
Voice Handicap Index (VHI) self-questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil group | bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction Receives: 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 Receives: Other: Voice Handicap Questionnaire (VHI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month post-intubation
Secondary outcomes (1)
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).
Measured: 6 month post-intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start16 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364633
- Sponsor's protocol ID
- RC20_0058
- Acronym
- VHIntubation
- Status last verified
- Sep 2021
- First submitted
- 24 Apr 2020
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04364633
- Acronym / sponsor ID
- VHIntubation / RC20_0058
- Conditions
- Intubation Complication
- Keywords
- Intra-tracheal intubation, Voice Handicap, Remifentanil, Curarization
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil group | – | Other: Voice Handicap Questionnaire (VHI)bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction |
| Neuromuscular blockade group | – | Other: Voice Handicap Questionnaire (VHI)Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice Handicap Questionnaire (VHI)Voice Handicap Index (VHI) self-questionnaire | Other | Neuromuscular blockade group, Remifentanil group |
Primary outcome
Voice Handicap at 1 month post-intubation
Time frame: 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 secondary outcome
Voice Handicap at 6 month post-intubation
Time frame: 6 month post-intubation
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation Complication, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice Handicap at 1 month post-intubation (time frame: 1 month post-intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.