IntubationInSizeS25NCT03339141
Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine
A study testing Intubation position in people with Intubation and Intratracheal, run by University Hospital, Clermont-Ferrand at 6 sites in France.
Trial summary
Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Intubation position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 6 sitesFrance
- Study dates
- 29 Nov 2017to 19 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - patients scheduled for various surgeries requiring general anesthesia with curare, with intubation of the trachea, eligible for intubation by direct laryngoscopy.
- > 18 years
- patients with social security
Who cannot join
- Emergency surgery.
- Patient who requiring rapid sequence induction.
- Intubation without curare.
- Expected difficult intubation with planned modification of the intubation protocol (i. e. intubation under fibroscopy, airtrach or videolaryngoscopy)
- Patient with a history of epilepsy, pulmonary or cardiovascular disease (including ischemic heart disease, symptomatic asthma or obstructive pulmonary disease).
- Patient with mask phobia.
Show all 9Show fewer
- BMI> 30kg / m2
- Patient who are refusing to take part.
- Patient protected major, minor, pregnant women, patients deemed incapable of giving informed consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Pôle Santé République
Clermont-Ferrand
Centre Hospitalier Alpes-Léman
Contamine-sur-Arve
Polyclinique Saint Odilon
Moulins, 03000
Hôpital Saint-Louis / AP-HP
Paris
Hôpital Nord-Ouest
Villefranche-sur-Saône
About this study
Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.
The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position
Read the detailed description
Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group).
Interim analysis every 100 patients.
- Conditions
- Intubation, Intratracheal
- Being tested
- Intubation position
- Keywords
- Intubation conditions, Anaesthetic techniques, Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation positionProcedure or surgery
The investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score).
| Study group | Role | What they receive |
|---|---|---|
| supine position | Placebo comparator | Patients are placed in the supine position at 0° from arrival in the room until intubation Receives: Procedure: Intubation position |
| 25° head-up position | Active comparator | Patients are placed in the 25° head-up position (half-seat or whole body proclive) from arrival in the room until intubation. Receives: Procedure: Intubation position |
What is being measured
The primary outcome is the main question the study is designed to answer.
POGO score
valid score observed by the anesthetist performing intubation at the time of intubation. POGO score means Percentage of Glottic Opening : from 0% (none visualization of the glottic opening, worst result) to 100% (complete visualization of the glottic opening, best result), from the anterior curvature of the vocal cords to the interarytenoid node, between the posterior cartilage
Measured: at day 1
Secondary outcomes (5)
Cormack-Lehane grade
another valid score observed by the anesthetist performing intubation at the time of intubation. It classifies views obtained by direct laryngoscopy based on the structures seen. From 1 (best result) to 4 (worst result). 1 : full view of glottis (POGO 100%) / 2 : partial view of glottis / 3 : only epiglottis seen, none of glottis seen (POGO 0%) / 4 : Neither glottis nor epiglottis seen (POGO 0%).
Measured: at day 1
Intubation operator's comfort
visual analog scale about the operator's comfort during intubation. It's a subjective score. It's an evaluation of the comfort of the intubation position from 0 to 10, where 0 is a total discomfort, a painful, very uncomfortable position and 10 is an optimal, very comfortable position.
Measured: at day 1
Episodes of desaturation and episodes of hypotension
SpO2 <90% or MAP <65mmHg or drop> 20% of the patient's baseline SBP
Measured: at ady 1
Mechanical complications of intubation:
laryngeal pain, hoarseness, upper airway trauma
Measured: at day 1
Patient height
at the tragus of the ear during intubation.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start29 Nov 2017
- Primary completion18 Sep 2021
- Study completion19 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Etienne BAZIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339141
- Sponsor's protocol ID
- CHU-361
- Other IDs
- 2016-A02078-43
- Acronym
- InSizeS25
- Status last verified
- Oct 2021
- First submitted
- 8 Nov 2017
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Falempin AS, Pereira B, Binakdane F, Bazin JE, Smirdec M. Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25 degrees head-up position and supine: the InSize25 study protocol. BMJ Open. 2019 Nov 3;9(11):e029761. doi: 10.1136/bmjopen-2019-029761.
PubMed 31685496
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine
- ClinicalTrials.gov ID
- NCT03339141
- Acronym / sponsor ID
- InSizeS25 / CHU-361
- Conditions
- Intubation, Intratracheal
- Keywords
- Intubation conditions, Anaesthetic techniques, Laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 13 Nov 2017 (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.
Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.
The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position
Detailed description
Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group).
Interim analysis every 100 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine position | Placebo comparator | Procedure: Intubation positionPatients are placed in the supine position at 0° from arrival in the room until intubation |
| 25° head-up position | Active comparator | Procedure: Intubation positionPatients are placed in the 25° head-up position (half-seat or whole body proclive) from arrival in the room until intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - patients scheduled for various surgeries requiring general anesthesia with curare, with intubation of the trachea, eligible for intubation by direct laryngoscopy.
- > 18 years
- patients with social security
Key exclusion criteria (9 listed)
- Emergency surgery.
- Patient who requiring rapid sequence induction.
- Intubation without curare.
- Expected difficult intubation with planned modification of the intubation protocol (i. e. intubation under fibroscopy, airtrach or videolaryngoscopy)
- Patient with a history of epilepsy, pulmonary or cardiovascular disease (including ischemic heart disease, symptomatic asthma or obstructive pulmonary disease).
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 |
|---|---|---|
| Intubation positionThe investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score). | Procedure or surgery | 25° head-up position, supine position |
Primary outcome
POGO score
Time frame: at day 1
valid score observed by the anesthetist performing intubation at the time of intubation. POGO score means Percentage of Glottic Opening : from 0% (none visualization of the glottic opening, worst result) to 100% (complete visualization of the glottic opening, best result), from the anterior curvature of the vocal cords to the interarytenoid node, between the posterior cartilage
5 secondary outcomes
Cormack-Lehane grade
Time frame: at day 1
Intubation operator's comfort
Time frame: at day 1
Episodes of desaturation and episodes of hypotension
Time frame: at ady 1
Mechanical complications of intubation:
Time frame: at day 1
Patient height
Time frame: at day 1
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 22 Oct 2021.
- Derived from this study: PubMed 31685496Falempin AS, Pereira B, Binakdane F, Bazin JE, Smirdec M. Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25 degrees head-up position and supine: the InSize25 study protocol. BMJ Open. 2019 Nov 3;9(11):e029761. doi: 10.1136/bmjopen-2019-029761.
Related trials for Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
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.
Jean-Etienne BAZIN principal investigator
University Hospital, Clermont-Ferrand
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation position in people with Intubation and Intratracheal, run by University Hospital, Clermont-Ferrand at 6 sites 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 3 inclusion and 9 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 22 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 6 sites 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. Some participants in this study may receive a placebo. 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?
POGO score (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339141, which also lists 1 linked publication.
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 22 Oct 2021.