Orotracheal IntubationPerson-OTINCT07647718
Does a Customized Intubation Facility Reduce Incidence of Difficulty
A study testing patient with personalized installation with AirPal RAMP™ mattress in people with Orotracheal Intubation, run by Hopital Foch at 1 site in France.
Trial summary
The idea of this study is to demonstrate that the position of the head at a comfort height spontaneously expressed by the patient, between Jackson's amended position or Ramp position, significantly improves the quality of the intubation gesture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orotracheal Intubation
- What is being tested?
- patient with personalized installation with AirPal RAMP™ mattress
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2022to 12 Jan 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women over 18 and under 80;
- Must undergo general anesthesia with oral intubation using a standard intubation probe;
- Can be contacted directly by telephone if they are patients treated in outpatient surgery;
- Having signed a consent form;
- Being affiliated to a Health Insurance scheme.
Who cannot join
- pregnant or breastfeeding patients;
- patients with a predicted difficulty in mask ventilation or intubation according to the assessment of the doctor who performs the clinical examination prior to inclusion (Arne score ≥ 11) or the one who takes care of the patient in the block operative;
- patients for whom the surgery requires the placement of a double-lumen tube;
- patients requiring rapid sequence induction;
- patients for whom induction cannot be carried out by the sufentanil, propofol, atracurium or rocuronium sequence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Customized Intubation Facility Reduce Incidence of Difficulty: Randomized Multicenter Trial?
The idea of this study is to demonstrate that the position of the head at a comfort height spontaneously expressed by the patient, between Jackson's amended position or Ramp position, significantly improves the quality of the intubation gesture. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress.
Thus the investigators can assume that the appropriate positioning and use of a video laryngoscope (McGrathR Mac) places the patient in the best anatomical configuration to breathe and, indirectly to facilitate control of the airways, especially for those with a risk of difficult airway management.
Read the detailed description
- Position for orotracheal intubation The period preceding the administration of anesthetic agents is essential to ensure a satisfactory oxygen supply (pre-oxygenation). Then, once loss of consciousness is achieved, an interface (oral intubation probe) is put in place to allow mechanical ventilation during the procedure. This phase can be marked by a more or less expected difficulty depending on the risk factors presented by the patient. Thus an Arne score> 11 is predictive of a potential difficulty which may lead to an alternative technique being proposed. Simple techniques also exist in the patient setup to reduce the incidence of difficulties. Among them, the placement of a cushion under the head with a slight extension of the head of 20 ° (Jackson's amended position) is recommended because it allows to obtain the alignment of the posterior pharyngeal and glottic spaces. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress. This optimization of the position according to the patient, between Jackson's amended position or Ramp position, opens up the prospect of defining an optimal position personalized to each patient. Thus, it can be assumed that the appropriate positioning places the patient in the best anatomical configuration for breathing and, indirectly, to facilitate control of the airways.
- Video laryngoscope The use of a video laryngoscope (McGrathR Mac) is becoming widespread in anesthesia, especially for the management of patients at risk of difficult airway management. This device by the video support at the end of the blade provides a better visualization of the glottic orifice.
- The hypothesis of this research The idea of this study is to demonstrate that the position of the head at a height of comfort spontaneously expressed by the patient significantly improves the quality of the intubation procedure.
- Conditions
- Orotracheal Intubation
- Being tested
- patient with personalized installation with AirPal RAMP™ mattress
- Keywords
- AirPal RAMP ™ mattress, McGrathR Mac ™ video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient with personalized installation with AirPal RAMP™ mattressProcedure or surgery
patient with personalized installation until a comfortable position is reached
| Study group | Role | What they receive |
|---|---|---|
| Custom | Experimental | patient with installation on an infused airbag until a comfortable position is reached Receives: Procedure: patient with personalized installation with AirPal RAMP™ mattress |
| Control | No intervention | Jackson's amended position with placement of a 6 cm high cushion under the patient's head |
What is being measured
The primary outcome is the main question the study is designed to answer.
the impact of a custom installation versus a conventional Jackson amended installation with a 6-centimeter cushion under the patient's head to facilitate orotracheal intubation
the proportion of orotracheal intubations for which third party assistance is required
Measured: 1 day
Secondary outcomes (6)
Assessment of the effect of patient positioning on the quality of exposure during intubation
- the duration of the intubation;
- the quality of visualization of the glottis;
- failure of intubation defined by reexposure, by esophageal intubation;
- the calculation of the Intubation Difficulty Scale (or IDS)
Measured: 1 day
Determination of the most frequent complementary resettlement actions
- the ideal position chosen by the patient (and measured) before the start of the procedure;
- the patient's position (measured) when the intubation is successful. The intubation time will be correlated with these measurements and the angles that will be deduced from them;
- additional techniques used at the time of intubation.
Measured: 1 day
Assessment of the quality of manual ventilation before intubation (peroxygenation)
- the use of a Guédel cannula;
- the number of hands required for ventilation;
- the percentage of leakage;
- minimal SpO2;
- maximum ETCO2.
Measured: 1 day
Assessment of the frequency and severity of complications of intubation
The complications of intubation was defined by the pharyngeal pain the day after surgery, dysphonia, an irritative cough reported by the patient and atelectasis.
Measured: 2 days
Assessment of patient comfort and the doctor's opinion on the technique
The doctor's opinion on the technique was defined by the regard to pre-oxygenation, peroxygenation, and intubation.
Measured: 1 day
Safety assessment of the technique
Safety was evaluated by the occurrence of a fall of the head, occurrence of a fall of the patient, accidental extubation, the incidence of arterial oxygen desaturation, the lowest arterial oxygen saturation and the perception of difficulty in intubation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start5 Jan 2022
- Primary completion5 Jan 2024
- Study completion12 Jan 2024
Why it stopped: The manufacturer of the mattress has gone bankrupt
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647718
- Sponsor's protocol ID
- 2020_0030
- Acronym
- Person-OTI
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Customized Intubation Facility Reduce Incidence of Difficulty: Randomized Multicenter Trial?
- ClinicalTrials.gov ID
- NCT07647718
- Acronym / sponsor ID
- Person-OTI / 2020_0030
- Conditions
- Orotracheal Intubation
- Keywords
- AirPal RAMP ™ mattress, McGrathR Mac ™ video laryngoscope
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The manufacturer of the mattress has gone bankrupt
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 15 Jun 2026 (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.
The idea of this study is to demonstrate that the position of the head at a comfort height spontaneously expressed by the patient, between Jackson's amended position or Ramp position, significantly improves the quality of the intubation gesture. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress.
Thus the investigators can assume that the appropriate positioning and use of a video laryngoscope (McGrathR Mac) places the patient in the best anatomical configuration to breathe and, indirectly to facilitate control of the airways, especially for those with a risk of difficult airway management.
Detailed description
- Position for orotracheal intubation The period preceding the administration of anesthetic agents is essential to ensure a satisfactory oxygen supply (pre-oxygenation). Then, once loss of consciousness is achieved, an interface (oral intubation probe) is put in place to allow mechanical ventilation during the procedure. This phase can be marked by a more or less expected difficulty depending on the risk factors presented by the patient. Thus an Arne score> 11 is predictive of a potential difficulty which may lead to an alternative technique being proposed. Simple techniques also exist in the patient setup to reduce the incidence of difficulties. Among them, the placement of a cushion under the head with a slight extension of the head of 20 ° (Jackson's amended position) is recommended because it allows to obtain the alignment of the posterior pharyngeal and glottic spaces. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress. This optimization of the position according to the patient, between Jackson's amended position or Ramp position, opens up the prospect of defining an optimal position personalized to each patient. Thus, it can be assumed that the appropriate positioning places the patient in the best anatomical configuration for breathing and, indirectly, to facilitate control of the airways.
- Video laryngoscope The use of a video laryngoscope (McGrathR Mac) is becoming widespread in anesthesia, especially for the management of patients at risk of difficult airway management. This device by the video support at the end of the blade provides a better visualization of the glottic orifice.
- The hypothesis of this research The idea of this study is to demonstrate that the position of the head at a height of comfort spontaneously expressed by the patient significantly improves the quality of the intubation procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom | Experimental | Procedure: patient with personalized installation with AirPal RAMP™ mattresspatient with installation on an infused airbag until a comfortable position is reached |
| Control | No intervention | –Jackson's amended position with placement of a 6 cm high cushion under the patient's head |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women over 18 and under 80;
- Must undergo general anesthesia with oral intubation using a standard intubation probe;
- Can be contacted directly by telephone if they are patients treated in outpatient surgery;
- Having signed a consent form;
- Being affiliated to a Health Insurance scheme.
Key exclusion criteria (5 listed)
- pregnant or breastfeeding patients;
- patients with a predicted difficulty in mask ventilation or intubation according to the assessment of the doctor who performs the clinical examination prior to inclusion (Arne score ≥ 11) or the one who takes care of the patient in the block operative;
- patients for whom the surgery requires the placement of a double-lumen tube;
- patients requiring rapid sequence induction;
- patients for whom induction cannot be carried out by the sufentanil, propofol, atracurium or rocuronium sequence.
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 |
|---|---|---|
| patient with personalized installation with AirPal RAMP™ mattresspatient with personalized installation until a comfortable position is reached | Procedure or surgery | Custom |
Primary outcome
the impact of a custom installation versus a conventional Jackson amended installation with a 6-centimeter cushion under the patient's head to facilitate orotracheal intubation
Time frame: 1 day
the proportion of orotracheal intubations for which third party assistance is required
6 secondary outcomes
Assessment of the effect of patient positioning on the quality of exposure during intubation
Time frame: 1 day
Determination of the most frequent complementary resettlement actions
Time frame: 1 day
Assessment of the quality of manual ventilation before intubation (peroxygenation)
Time frame: 1 day
Assessment of the frequency and severity of complications of intubation
Time frame: 2 days
Assessment of patient comfort and the doctor's opinion on the technique
Time frame: 1 day
Safety assessment of the technique
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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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?
A study testing patient with personalized installation with AirPal RAMP™ mattress in people with Orotracheal Intubation, run by Hopital Foch 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: withdrawn, as of the sponsor's last update on 15 Jun 2026. 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 withdrawn before enrolling participants, so there are no results.
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?
the impact of a custom installation versus a conventional Jackson amended installation with a 6-centimeter cushion under the patient's head to facilitate orotracheal intubation (time frame: 1 day). 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 15 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.