Respiratory ComplicationESCORTENCT04159220
Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care
A study testing Clamping of the ventilator endotracheal tube in people with Respiratory Complication, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Intra hospital transport of ICU patients is still at high risk of respiratory complications.We propose to determine if endotracheal tube clamping prior to disconnect ventilator allows to avoid oxygenation decrease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Complication
- What is being tested?
- Clamping of the ventilator endotracheal tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2020to 22 Dec 2023
- 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
- intensive care patient
- intubated, sedated, controlled assisted ventilation
- Intra hospital transport for CT scan
- arterial catheter
- the patient or his trusted person consent to the study
Who cannot join
- Patient Covid tests positive or Covid test results not received
- extubated, unsedated,
- reinforced tube
- tracheotomy
- pregnancy
- guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Departement d'anesthésie et réanimation Gui de Chauliac (DAR C)
Montpellier, 34295
About this study
Official title: Randomized Controlled Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care
Intra hospital transport of ICU patients is still at high risk of respiratory complications.We propose to determine if endotracheal tube clamping prior to disconnect ventilator allows to avoid oxygenation decrease.
Read the detailed description
Changing respiratory support and multiples endotracheal tube disconnections may induce a loss of PEEP and finally lead to alveolar derecruitment. This study is an evaluation of a care procedure to limit the incidence of alveolar derecruitment in ventilated intubated ICU patients during transport for CT scan.
Intra hospital transport of ICU patients are performed by anesthesiologist nurses, the physician entrusts them this activity.
This is a randomized controlled study, the procedure is to clamp endotracheal tube before each disconnection from ventilator.
- Conditions
- Respiratory Complication
- Being tested
- Clamping of the ventilator endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamping of the ventilator endotracheal tubeProcedure or surgery
The transport will be released in accordance with SFAR SRLF guideline. Before each disconnection from ventilator endotracheal tube will be clamped.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The transport will be released without a clamping of endotracheal tube before each disconnection from ventilator. |
| Clamping group | Experimental | The transport will be released with a clamping of endotracheal tube before each disconnection from ventilator. Receives: Procedure: Clamping of the ventilator endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the pa02/Fi02
Evaluate the effectiveness of a procedure to avoid alveolar delisting, measured by the absence of a decrease in the PaO2/FiO2 ratio (before transport and 1 hour after return to bed) during an HIT performed by a nurse anaesthetist/caregiver team, of intubated and ventilated resuscitation patients in a controlled assisted volume.
Measured: 1 hour after the end of the transport
Secondary outcomes (6)
Assessment of the pa02
Evaluate the impact of the procedure on the absence of PaO2 reduction (before transport and 1 hour after return to bed)
Measured: 1 hour after the end of the HIT
Assessment of the pa02
Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator
Measured: immediately after the end of the HIT
Assessment of the pa02
Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator
Measured: 6 hours after the end of of the HIT
length of stay
Evaluate the impact of the intervention on the length of ICU stay
Measured: up to 28 days
duration of invasive ventilation
Evaluate the impact of the intervention on the invasive ventilation
Measured: up to 28 days
occurrence of adverse events during the HIT
occurrence of adverse events related to the clamping
Measured: immediately after the end of the HIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start17 Jan 2020
- Primary completion18 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159220
- Sponsor's protocol ID
- RECHMPL19_0070
- Acronym
- ESCORTE
- Status last verified
- May 2024
- First submitted
- 6 Nov 2019
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care
- ClinicalTrials.gov ID
- NCT04159220
- Acronym / sponsor ID
- ESCORTE / RECHMPL19_0070
- Conditions
- Respiratory Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 12 Nov 2019 (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.
Intra hospital transport of ICU patients is still at high risk of respiratory complications.We propose to determine if endotracheal tube clamping prior to disconnect ventilator allows to avoid oxygenation decrease.
Detailed description
Changing respiratory support and multiples endotracheal tube disconnections may induce a loss of PEEP and finally lead to alveolar derecruitment. This study is an evaluation of a care procedure to limit the incidence of alveolar derecruitment in ventilated intubated ICU patients during transport for CT scan.
Intra hospital transport of ICU patients are performed by anesthesiologist nurses, the physician entrusts them this activity.
This is a randomized controlled study, the procedure is to clamp endotracheal tube before each disconnection from ventilator.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The transport will be released without a clamping of endotracheal tube before each disconnection from ventilator. |
| Clamping group | Experimental | Procedure: Clamping of the ventilator endotracheal tubeThe transport will be released with a clamping of endotracheal tube before each disconnection from ventilator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- intensive care patient
- intubated, sedated, controlled assisted ventilation
- Intra hospital transport for CT scan
- arterial catheter
- the patient or his trusted person consent to the study
Key exclusion criteria (6 listed)
- Patient Covid tests positive or Covid test results not received
- extubated, unsedated,
- reinforced tube
- tracheotomy
- pregnancy
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 |
|---|---|---|
| Clamping of the ventilator endotracheal tubeThe transport will be released in accordance with SFAR SRLF guideline. Before each disconnection from ventilator endotracheal tube will be clamped. | Procedure or surgery | Clamping group |
Primary outcome
Measure of the pa02/Fi02
Time frame: 1 hour after the end of the transport
Evaluate the effectiveness of a procedure to avoid alveolar delisting, measured by the absence of a decrease in the PaO2/FiO2 ratio (before transport and 1 hour after return to bed) during an HIT performed by a nurse anaesthetist/caregiver team, of intubated and ventilated resuscitation patients in a controlled assisted volume.
6 secondary outcomes
Assessment of the pa02
Time frame: 1 hour after the end of the HIT
Assessment of the pa02
Time frame: immediately after the end of the HIT
Assessment of the pa02
Time frame: 6 hours after the end of of the HIT
length of stay
Time frame: up to 28 days
duration of invasive ventilation
Time frame: up to 28 days
occurrence of adverse events during the HIT
Time frame: immediately after the end of the HIT
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 31 May 2024.
- Individual participant dataSharing planned: Yes
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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 Clamping of the ventilator endotracheal tube in people with Respiratory Complication, run by University Hospital, Montpellier 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 6 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 31 May 2024. 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?
Measure of the pa02/Fi02 (time frame: 1 hour after the end of the transport). 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 31 May 2024.