Cuff OverinflationCPRATIC-2NCT04413318
Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children
A study testing Electronic device (VBM©) and Pneumatic device (Nosten©) in people with Cuff Overinflation and Cuff Underinflation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. Read more about this study
- Who is it for?
- Ages 2 days to 5 years
- Conditions the study is for
- Cuff Overinflation, Cuff Underinflation
- What is being tested?
- Electronic device (VBM©) and Pneumatic device (Nosten©)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 12 Aug 2020to 16 Apr 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 2 days to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and children more than 2 days after birth at term and less than 5 years of age
- Patient intubated in the PICU with a cuffed endotracheal tube
- Predicted duration of mechanical ventilation > or = 24-hours
- Signed informed consent
Who cannot join
- Intubated with an uncuffed endotracheal tube
- Children admitted to the PICU with a previous tracheostomy
- Preterm children or infants less than 2 days post-term
- Patient under block neuromuscular treatment
- Patient enrolled in another trial that might influence this study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-over Study to Compare Two Different Tracheal Cuff Pressure Monitoring Devices in a Pediatric Intensive Care Unit
Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.
Read the detailed description
In this study, the investigators will compare the duration of the period of under-inflation and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous monitoring of tracheal cuff pressure), in critically intubated children. This study aims to determine the effectiveness of the electronic device in the continuous monitoring of tracheal cuff pressure.
- Conditions
- Cuff Overinflation, Cuff Underinflation
- Being tested
- Electronic device (VBM©), Pneumatic device (Nosten©)
- Keywords
- tracheal cuff pressure, pediatric critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic device (VBM©)Device
Continuous control of tracheal cuff pressure using an electronic device (VBM©) for 6-hours followed by continuous control using a pneumatic device (Nosten©) for 6-hours.
Pneumatic device (Nosten©)Device
Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).
| Study group | Role | What they receive |
|---|---|---|
| electronic device followed by pneumatic device | Experimental | Children receive continuous control of tracheal cuff pressure with the electronic device (VBM©) for 6-hours followed by continuous control of tracheal cuff pressure with the pneumatic device (Nosten©) for 6-hours. Receives: Device: Electronic device (VBM©) |
| pneumatic device followed by electronic device | Experimental | Children receive the reverse sequence (continuous control using the pneumatic device (Nosten©) for 6-hours followed by the electronic device (VBM©) for 6-hours Receives: Device: Pneumatic device (Nosten©) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spend with over or under-inflation of the tracheal cuff
Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). The period was speared by a time of wash-out of 30 minutes
Measured: 12 hours
Secondary outcomes (1)
The response time to a significant variation in cuff pressure
Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). Automated analysis of the response time in milliseconds to a change in cuff pressure of at least 15% above or below the target value
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start12 Aug 2020
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff OverinflationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris LACARRA, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisStephane DAUGER, MD PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413318
- Sponsor's protocol ID
- APHP190869
- Other IDs
- IDRCB: 2019-A02246-51
- Acronym
- CPRATIC-2
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 18 Oct 2021
- 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 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-over Study to Compare Two Different Tracheal Cuff Pressure Monitoring Devices in a Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04413318
- Acronym / sponsor ID
- CPRATIC-2 / APHP190869
- Conditions
- Cuff Overinflation, Cuff Underinflation
- Keywords
- tracheal cuff pressure, pediatric critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 2 Jun 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.
Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.
Detailed description
In this study, the investigators will compare the duration of the period of under-inflation and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous monitoring of tracheal cuff pressure), in critically intubated children. This study aims to determine the effectiveness of the electronic device in the continuous monitoring of tracheal cuff pressure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electronic device followed by pneumatic device | Experimental | Device: Electronic device (VBM©)Children receive continuous control of tracheal cuff pressure with the electronic device (VBM©) for 6-hours followed by continuous control of tracheal cuff pressure with the pneumatic device (Nosten©) for 6-hours. |
| pneumatic device followed by electronic device | Experimental | Device: Pneumatic device (Nosten©)Children receive the reverse sequence (continuous control using the pneumatic device (Nosten©) for 6-hours followed by the electronic device (VBM©) for 6-hours |
Who may qualify
- Ages
- 2 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants and children more than 2 days after birth at term and less than 5 years of age
- Patient intubated in the PICU with a cuffed endotracheal tube
- Predicted duration of mechanical ventilation > or = 24-hours
- Signed informed consent
Key exclusion criteria (5 listed)
- Intubated with an uncuffed endotracheal tube
- Children admitted to the PICU with a previous tracheostomy
- Preterm children or infants less than 2 days post-term
- Patient under block neuromuscular treatment
- Patient enrolled in another trial that might influence this study results
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 |
|---|---|---|
| Electronic device (VBM©)Continuous control of tracheal cuff pressure using an electronic device (VBM©) for 6-hours followed by continuous control using a pneumatic device (Nosten©) for 6-hours. | Device | electronic device followed by pneumatic device |
| Pneumatic device (Nosten©)Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©). | Device | pneumatic device followed by electronic device |
Primary outcome
Percentage of time spend with over or under-inflation of the tracheal cuff
Time frame: 12 hours
Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). The period was speared by a time of wash-out of 30 minutes
1 secondary outcome
The response time to a significant variation in cuff pressure
Time frame: 12 hours
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 18 Oct 2021.
- Individual participant dataSharing planned: No
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.
Boris LACARRA, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Stephane DAUGER, MD PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic device (VBM©) and Pneumatic device (Nosten©) in people with Cuff Overinflation and Cuff Underinflation, run by Assistance Publique - Hôpitaux de Paris 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: finished, as of the sponsor's last update on 18 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?
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?
Percentage of time spend with over or under-inflation of the tracheal cuff (time frame: 12 hours). 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 18 Oct 2021.