Endotracheal IntubationMacSizeNCT05059067
Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.
An observational study of Endotracheal Intubation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Endotracheal intubation is a frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital) but optimal Macintosh blade size remains unknown to date. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Direct laryngoscopy for endotracheal intubation
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 1 Jan 2022
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient requiring orotracheal intubation with direct laryngoscopy
Who may be able to join
- Patients must be admitted in an operative room, an intensive care unit (ICU) or an emergency department and require mechanical ventilation through an orotracheal tube.
- Adult (age ≥ 18 years)
- Subjects must be covered by public health insurance
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Who cannot join
- Anticipated difficult intubation requiring videolaryngoscopy
- Nasotracheal intubation
- Refusal of study participation or to pursue the study by the patient
- Absence of coverage by the French statutory healthcare insurance system
- Protected person
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Clermont-Ferrand
Thomas Godet, tgodet@chu-clermontferrand.fr
About this study
Endotracheal intubation is a frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital) but optimal Macintosh blade size remains unknown to date.
Read the detailed description
Endotracheal intubation is an extremely frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital). Apart from special cases of foreseen difficult programmed intubation, direct laryngoscopy remains the most frequently used technique. It requires the use of a handle (short or long), which serves as a light source on which is adapted a Macintosh curved blade, metallic or plastic, single or multiple use. The choice of blade size is based on the experience of the physician. Most often, in adult settings, size 3 or 4 blades are used. The very spartan literature on the subject and the current recommendations do not provide any information on the choice of blade size. We therefore wish to evaluate these practices in terms of success of the first laryngoscopy, Cormack-Lehane and POGO (percentage of glottic opening visualized) scores, the need to use an alternative technique or a second operator. The results will be analyzed with regard as a function and experience of the person performing the laryngoscopy, as well as the setting (urgent or scheduled). These data are usually collected during the performance of an endotracheal intubation whatever the circumstances: operating room, intensive care unit and emergency department (in-hospital) and in the SAMU-SMUR (pre-hospiatl medical service) at Clermont-Ferrand University Hospital.
- Conditions
- Endotracheal Intubation
- Being tested
- Direct laryngoscopy for endotracheal intubation
- Keywords
- Intubation, Macintosh blade, Laryngoscopie, Operative room, Intensive Care Unit, Emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct laryngoscopy for endotracheal intubationDevice
Patients in operative room, intensive care unit and emergency department requiring direct laryngoscopy for endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Macintosh blade size 3 | Patients intubated using Macintosh blade size 3 Receives: Device: Direct laryngoscopy for endotracheal intubation | |
| Macintosh blade size 4 | Patients intubated using Macintosh blade size 4 Receives: Device: Direct laryngoscopy for endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful first-pass orotracheal intubation
The proportion of patients with successful first-pass orotracheal intubation
Measured: At intubation
Secondary outcomes (15)
Severe complications related to intubation_hypoxemia
Rate of severe hypoxemia defined by lowest oxygen saturation (SpO2) < 80 %
Measured: At intubation
Severe complications related to intubation_severe collapse
Rate of cardiovascular collapse, defined as systolic blood pressure less than 65 mm Hg recorded at least once or less than 90 mm Hg lasting 30 minutes despite 500-1,000 ml of fluid loading (crystalloids solutions) or requiring introduction or increasing doses by more than 30% of vasoactive support
Measured: At intubation
Severe complications related to intubation_cardiac arrest
Rate of cardiac arrest
Measured: At intubation
Severe complications related to intubation_death
Rate of death during intubation
Measured: At intubation
Moderate complications related to intubation_difficult intubation
Rate of difficult intubation
Measured: At intubation
Moderate complications related to intubation_arrythmia
Rate of severe ventricular or supraventricular arrhythmia requiring intervention
Measured: At intubation
Moderate complications related to intubation_oesophageal intubation
Rate of oesophageal intubation
Measured: At intubation
Moderate complications related to intubation_agitation
Rate of agitation
Measured: At intubation
Moderate complications related to intubation_aspiration
Rate of pulmonary aspiration
Measured: At intubation
Moderate complications related to intubation_dental injuries
Rate of dental injuries
Measured: At intubation
Cormack Lehane
Rate of Cormack-Lehane grade of glottic view
Measured: During intubation
Difficulty of intubation
Rate of operator-assessed difficulty of intubation
Measured: During intubation
Additional airway equipment
Rate of need for additional airway equipment (video laryngoscope, bougie, stylet, fibroscope, cricothyrotomy)
Measured: During intubation
Additional second operator
Rate of need for a second operator
Measured: During intubation
POGO (percentage of glottic opening)
Rate of POGO grade of glottic view
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Jun 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Godet, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059067
- Sponsor's protocol ID
- IRB 00010254-2021-016
- Acronym
- MacSize
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 5 Oct 2021
- 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 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05059067
- Acronym / sponsor ID
- MacSize / IRB 00010254-2021-016
- Conditions
- Endotracheal Intubation
- Keywords
- Intubation, Macintosh blade, Laryngoscopie, Operative room, Intensive Care Unit, Emergency department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 28 Sep 2021 (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.
Endotracheal intubation is a frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital) but optimal Macintosh blade size remains unknown to date.
Detailed description
Endotracheal intubation is an extremely frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital). Apart from special cases of foreseen difficult programmed intubation, direct laryngoscopy remains the most frequently used technique. It requires the use of a handle (short or long), which serves as a light source on which is adapted a Macintosh curved blade, metallic or plastic, single or multiple use. The choice of blade size is based on the experience of the physician. Most often, in adult settings, size 3 or 4 blades are used. The very spartan literature on the subject and the current recommendations do not provide any information on the choice of blade size. We therefore wish to evaluate these practices in terms of success of the first laryngoscopy, Cormack-Lehane and POGO (percentage of glottic opening visualized) scores, the need to use an alternative technique or a second operator. The results will be analyzed with regard as a function and experience of the person performing the laryngoscopy, as well as the setting (urgent or scheduled). These data are usually collected during the performance of an endotracheal intubation whatever the circumstances: operating room, intensive care unit and emergency department (in-hospital) and in the SAMU-SMUR (pre-hospiatl medical service) at Clermont-Ferrand University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh blade size 3 | – | Device: Direct laryngoscopy for endotracheal intubationPatients intubated using Macintosh blade size 3 |
| Macintosh blade size 4 | – | Device: Direct laryngoscopy for endotracheal intubationPatients intubated using Macintosh blade size 4 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient requiring orotracheal intubation with direct laryngoscopy
Key inclusion criteria (4 listed)
- Patients must be admitted in an operative room, an intensive care unit (ICU) or an emergency department and require mechanical ventilation through an orotracheal tube.
- Adult (age ≥ 18 years)
- Subjects must be covered by public health insurance
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Key exclusion criteria (5 listed)
- Anticipated difficult intubation requiring videolaryngoscopy
- Nasotracheal intubation
- Refusal of study participation or to pursue the study by the patient
- Absence of coverage by the French statutory healthcare insurance system
- Protected person
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 |
|---|---|---|
| Direct laryngoscopy for endotracheal intubationPatients in operative room, intensive care unit and emergency department requiring direct laryngoscopy for endotracheal intubation | Device | Macintosh blade size 3, Macintosh blade size 4 |
Primary outcome
Number of patients with successful first-pass orotracheal intubation
Time frame: At intubation
The proportion of patients with successful first-pass orotracheal intubation
15 secondary outcomes
Severe complications related to intubation_hypoxemia
Time frame: At intubation
Severe complications related to intubation_severe collapse
Time frame: At intubation
Severe complications related to intubation_cardiac arrest
Time frame: At intubation
Severe complications related to intubation_death
Time frame: At intubation
Moderate complications related to intubation_difficult intubation
Time frame: At intubation
Moderate complications related to intubation_arrythmia
Time frame: At intubation
Moderate complications related to intubation_oesophageal intubation
Time frame: At intubation
Moderate complications related to intubation_agitation
Time frame: At intubation
Moderate complications related to intubation_aspiration
Time frame: At intubation
Moderate complications related to intubation_dental injuries
Time frame: At intubation
Cormack Lehane
Time frame: During intubation
Difficulty of intubation
Time frame: During intubation
Additional airway equipment
Time frame: During intubation
Additional second operator
Time frame: During intubation
POGO (percentage of glottic opening)
Time frame: During intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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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.
Thomas Godet principal investigator
University Hospital, Clermont-Ferrand
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 Endotracheal Intubation, run by University Hospital, Clermont-Ferrand 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 4 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: status not confirmed, as of the sponsor's last update on 5 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 4 73 754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful first-pass orotracheal intubation (time frame: At 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 5 Oct 2021.