Orotracheal IntubationHEMODAIRTRAQNCT03743831
Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq
A study testing orotracheal intubation by direct laryngoscopy and orotracheal intubation by indirect laryngoscopy in people with Orotracheal Intubation, run by University Hospital, Lille at 1 site in France.
Trial summary
News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but they are still too restricted to situations (difficult intubation criteria ..). It wanted to focus on indirect laryngoscopy by Airtraq. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orotracheal Intubation
- What is being tested?
- orotracheal intubation by direct laryngoscopy and orotracheal intubation by indirect laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2018to 31 Jul 2019
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Specific medical conditions: ASA 1 or 2
- Patient having given written consent to participate in the category 2 trial
- Intubation realized by experienced person
- Social Insured Patient
- Patient willing to comply with all procedures of the study and its duration
Who cannot join
- Demographic characteristics: minor, over 65
- Medical history: history of difficult intubation, hypertension
- Lille intubation score greater than or equal to 7
- Treatments in progress: Beta taking blocking the day of the operation.
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq, Controlled, Prospective, Randomized, Simple-blind, Monocentric Study at the Lille University Hospital Specialties Block.
News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but they are still too restricted to situations (difficult intubation criteria ..). It wanted to focus on indirect laryngoscopy by Airtraq. This technique allows better exposure during intubation while limiting mouth opening and cervical hyper extension, but also dental trauma and lip wounds. It also reduces the duration of laryngoscopy and therefore at the same time the apnea time. After a review of the literature, it has been proven that its use reduces haemodynamic changes during intubation. But these studies have been realized only in very particular patients (obese, heart failure) and with induction protocols that are not used routinely in our operating theaters.
Reasons why it decided to carry out this study, on the one hand to find these results and especially to be able to extend them to the whole population.
- Conditions
- Orotracheal Intubation
- Being tested
- orotracheal intubation by direct laryngoscopy, orotracheal intubation by indirect laryngoscopy
- Keywords
- Laryngoscopy direct, Laryngoscopy indirect by Airtraq, hemodynamic changes, side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orotracheal intubation by direct laryngoscopyDevice
Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch
orotracheal intubation by indirect laryngoscopyDevice
orotracheal intubation by indirect laryngoscopy by Airtraq
| Study group | Role | What they receive |
|---|---|---|
| orotracheal intubation direct | Other | Not described Receives: Device: orotracheal intubation by direct laryngoscopy |
| orotracheal intubation indirect | Other | Not described Receives: Device: orotracheal intubation by indirect laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from intubation mean blood pressure at 1 min after intubation
Measured: between the values before intubation (T0) and 1min after intubation.
Secondary outcomes (7)
Frequency of patients with hemodynamic reaction post intubation (minimal variation of mean blood pressure or heart rate of 20%
Measured: between values before intubation and 1, 2, 5, 10 minutes after intubation.
Variation of blood pressure (PAM)
Measured: between the values before intubation (T0) and 2, 5 and 10 minutes of intubation
Variation of heart rate (HR)
Measured: between the values before intubation (T0) and 1, 2, 5 and 10 minutes of intubation
Mean of the arterial blood pressure and heart rate
delta defined by the difference between the values
Measured: before intubation and at 1,2,5 and 10 minutes from intubation.
Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon
Measured: at 1 min after intubation
Frequency of patients with dental trauma and / or an injury to the lips due to the intubation device.
Measured: at 10 min after intubation
instantaneous ANI delta
Measured: between ANI before intubation and 1,2,5 and 10 min after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start4 Dec 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Vygon GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Elsa Jozefowicz, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743831
- Sponsor's protocol ID
- 2017_72
- Other IDs
- 2018-A01683-52
- Acronym
- HEMODAIRTRAQ
- Status last verified
- Mar 2020
- First submitted
- 14 Nov 2018
- Last updated
- 26 Mar 2020
- 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 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq, Controlled, Prospective, Randomized, Simple-blind, Monocentric Study at the Lille University Hospital Specialties Block.
- ClinicalTrials.gov ID
- NCT03743831
- Acronym / sponsor ID
- HEMODAIRTRAQ / 2017_72
- Conditions
- Orotracheal Intubation
- Keywords
- Laryngoscopy direct, Laryngoscopy indirect by Airtraq, hemodynamic changes, side effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Vygon GmbH & Co. KG
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 16 Nov 2018 (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.
News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but they are still too restricted to situations (difficult intubation criteria ..). It wanted to focus on indirect laryngoscopy by Airtraq. This technique allows better exposure during intubation while limiting mouth opening and cervical hyper extension, but also dental trauma and lip wounds. It also reduces the duration of laryngoscopy and therefore at the same time the apnea time. After a review of the literature, it has been proven that its use reduces haemodynamic changes during intubation. But these studies have been realized only in very particular patients (obese, heart failure) and with induction protocols that are not used routinely in our operating theaters.
Reasons why it decided to carry out this study, on the one hand to find these results and especially to be able to extend them to the whole population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orotracheal intubation direct | Other | Device: orotracheal intubation by direct laryngoscopy |
| orotracheal intubation indirect | Other | Device: orotracheal intubation by indirect laryngoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Specific medical conditions: ASA 1 or 2
- Patient having given written consent to participate in the category 2 trial
- Intubation realized by experienced person
- Social Insured Patient
- Patient willing to comply with all procedures of the study and its duration
Key exclusion criteria (5 listed)
- Demographic characteristics: minor, over 65
- Medical history: history of difficult intubation, hypertension
- Lille intubation score greater than or equal to 7
- Treatments in progress: Beta taking blocking the day of the operation.
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent
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 |
|---|---|---|
| orotracheal intubation by direct laryngoscopyOrotracheal intubation by direct laryngoscopy by metal blade type Macintosch | Device | orotracheal intubation direct |
| orotracheal intubation by indirect laryngoscopyorotracheal intubation by indirect laryngoscopy by Airtraq | Device | orotracheal intubation indirect |
Primary outcome
change from intubation mean blood pressure at 1 min after intubation
Time frame: between the values before intubation (T0) and 1min after intubation.
7 secondary outcomes
Frequency of patients with hemodynamic reaction post intubation (minimal variation of mean blood pressure or heart rate of 20%
Time frame: between values before intubation and 1, 2, 5, 10 minutes after intubation.
Variation of blood pressure (PAM)
Time frame: between the values before intubation (T0) and 2, 5 and 10 minutes of intubation
Variation of heart rate (HR)
Time frame: between the values before intubation (T0) and 1, 2, 5 and 10 minutes of intubation
Mean of the arterial blood pressure and heart rate
Time frame: before intubation and at 1,2,5 and 10 minutes from intubation.
Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon
Time frame: at 1 min after intubation
Frequency of patients with dental trauma and / or an injury to the lips due to the intubation device.
Time frame: at 10 min after intubation
instantaneous ANI delta
Time frame: between ANI before intubation and 1,2,5 and 10 min after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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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.
Elsa Jozefowicz, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orotracheal intubation by direct laryngoscopy and orotracheal intubation by indirect laryngoscopy in people with Orotracheal Intubation, run by University Hospital, Lille 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 26 Mar 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change from intubation mean blood pressure at 1 min after intubation (time frame: between the values before intubation (T0) and 1min after 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 26 Mar 2020.