AtelectasisPREVAT-PEDNCT03592589
Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia in Children
A study testing high flow nasal canula in people with Atelectasis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Anesthesia causes respiratory changes and complications, which are the main causes of complications and anesthesia-related deaths. Among the complications, the rapid appearance of lung atelectasis is well known, deteriorating the hematosis during anesthesia, and inducing secondary pulmonary complications. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- high flow nasal canula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2018to 27 Mar 2019
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Indication of general anesthesia for MRI
- Patient between 6 months and 5 years old
- ASA score I or II
- No facial dysmorphia
- No predicting difficult intubation
- Parental consent
Who cannot join
- Severe cardio-pulmonary disease
- Lack of coverage by health insurance
- ASA III or IV
- Parental refuse for inclusion
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13005
About this study
Official title: Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia for MRI by Sevoflurane in Children, Evaluated by Lung MRI and Echography
Anesthesia causes respiratory changes and complications, which are the main causes of complications and anesthesia-related deaths.
Among the complications, the rapid appearance of lung atelectasis is well known, deteriorating the hematosis during anesthesia, and inducing secondary pulmonary complications.
Read more
Prevention or limitation of the atelectasis would be a way to improve the safety of patients who have a limited respiratory function.
The application of a positive expiratory pressure (PEP) is an effective prevention method for atelectasis, that have been only demonstrate in patients under mechanical ventilation.
The high flow nasal cannula is a non-invasive technique easy to perform and allowing a PEP. High flow nasal cannula is safe to use, and the interface is free from local skin complications.
Chest X-ray (bad sensibility) or CT are usually used for the diagnosis of atelectasis, but these two exams involve irradiation for patient. MRI and pulmonary ultrasonography has now been validated in adults. MRI are relatively long, and allow to investigate the atelectasis with only a short additional acquisition time.
Thus, it would be the first study on the effect of the PEP on the impact and the volume of the atelectasis during general anesthesia in spontaneous ventilation in children. By the way this is the first study on lung's anatomical effects of high flow nasal cannula.
It is a monocentric, intervention, randomized, superiority study whose main purpose is to show the reduction of the atelectasis through the use of high flow nasal cannula versus a high concentration mask for pediatric anesthesia during MRI.
The studied population is all the children between 6 months and 5 years with a pediatric indication of general anesthesia for MRI.
The primary goal is to show a reduction of volume (cm3) of the atelectasis via the application of a PEP by high flow nasal cannula.
The main assessment criteria is the ratio of atelectasis volume/total lung volume.
The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software. The duration of the examination and the anesthesia is slighty lengthened, 3 to 5 minutes for a 40 minutes' exam.
The secondary objective is to show a match between the atelectasis on MRI and ultrasound.
Read the detailed description
Anesthesia causes respiratory changes and complications, which are the main causes of complications and anesthesia-related deaths.
Among the complications, the rapid appearance of lung atelectasis is well known, deteriorating the hematosis during anesthesia, and inducing secondary pulmonary complications.
Prevention or limitation of the atelectasis would be a way to improve the safety of patients who have a limited respiratory function.
The application of a positive expiratory pressure (PEP) is an effective prevention method for atelectasis, that has been demonstrated only in patients under mechanical ventilation.
The high flow nasal cannula is a non-invasive technique easy to perform and allowing a PEP. High flow nasal cannula is safe to use, and the interface is free from local skin complications.
Chest X-ray (bad sensibility) or CT are usually used for the diagnosis of atelectasis, but these two exams involve irradiation for patient. MRI and pulmonary ultrasonography has now been validated in adults. The investigators has a long experience of anesthesia in spontaneous ventilation in children for MRI. MRI are relatively long, and allow to investigate the atelectasis with only a short additional acquisition time.
Thus, it would be the first study on the effect of the PEP on the impact and the volume of the atelectasis during general anesthesia in spontaneous ventilation in children. By the way this is the first study on lung's anatomical effects of high flow nasal cannula.
It is a monocentric, intervention, randomized, superiority study whose main purpose is to show the reduction of the atelectasis through the use of high flow nasal cannula versus a high concentration mask for pediatric anesthesia during MRI.
The studied population is all the children between 6 months and 5 years with a pediatric indication of general anesthesia for MRI.
The primary goal is to show a reduction of volume (cm3) of the atelectasis via the application of a PEP by high flow nasal cannula.
The main assessment criteria is the ratio of atelectasis volume/total lung volume.
The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software. The duration of the examination and the anesthesia is slighty lengthened, 3 to 5 minutes for a 40 minutes' exam.
The secondary objective is to show a match between the atelectasis on MRI and ultrasound.
- Conditions
- Atelectasis
- Being tested
- high flow nasal canula
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal canulaDevice
high flow nasal canula to obtain a positive expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | standard general anesthesia using sevoflurane delivered by a pediatric high concentration mask |
| Intervention group | Experimental | sevoflurane will be deliver by a pediatric high flow nasal canula (2L/KG/min) Receives: Device: high flow nasal canula |
What is being measured
The primary outcome is the main question the study is designed to answer.
atelectasis volume by Lung MRI
volume (cm3) of the total lung.
The main assessment criteria is the ratio of atelectasis volume/total lung volume.
The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software.
Measured: 40 minutes
total lung volume by Lung MRI
volume (cm3) of the atelectasis via the application of a PEP by high flow nasal cannula.
The main assessment criteria is the ratio of atelectasis volume/total lung volume.
The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software.
Measured: 40 minutes
Secondary outcomes (1)
atelectasis volume by lung ultrasonography
Lung ultrasonography will be pratice in recovery room, just after the MRI. The Lung ultrasonography score will be collected.
Measured: 15 to 45 minutes after begining general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start10 Oct 2018
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
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 AtelectasisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592589
- Sponsor's protocol ID
- 2017-39
- Acronym
- PREVAT-PED
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2018
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roncin C, Scemama U, Zieleskiewicz L, Loundou A, Lesavre N, Vialet R. Atelectasis prevention during anaesthesia using high-flow nasal cannula therapy: A paediatric randomised trial using MRI images. Anaesth Crit Care Pain Med. 2020 Dec;39(6):819-824. doi: 10.1016/j.accpm.2020.08.009. Epub 2020 Oct 17.
PubMed 33080406
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia for MRI by Sevoflurane in Children, Evaluated by Lung MRI and Echography
- ClinicalTrials.gov ID
- NCT03592589
- Acronym / sponsor ID
- PREVAT-PED / 2017-39
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 19 Jul 2018 (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.
Anesthesia causes respiratory changes and complications, which are the main causes of complications and anesthesia-related deaths.
Among the complications, the rapid appearance of lung atelectasis is well known, deteriorating the hematosis during anesthesia, and inducing secondary pulmonary complications.
Prevention or limitation of the atelectasis would be a way to improve the safety of patients who have a limited respiratory function.
The application of a positive expiratory pressure (PEP) is an effective prevention method for atelectasis, that have been only demonstrate in patients under mechanical ventilation.
The high flow nasal cannula is a non-invasive technique easy to perform and allowing a PEP. High flow nasal cannula is safe to use, and the interface is free from local skin complications.
Chest X-ray (bad sensibility) or CT are usually used for the diagnosis of atelectasis, but these two exams involve irradiation for patient. MRI and pulmonary ultrasonography has now been validated in adults. MRI are relatively long, and allow to investigate the atelectasis with only a short additional acquisition time.
Thus, it would be the first study on the effect of the PEP on the impact and the volume of the atelectasis during general anesthesia in spontaneous ventilation in children. By the way this is the first study on lung's anatomical effects of high flow nasal cannula.
It is a monocentric, intervention, randomized, superiority study whose main purpose is to show the reduction of the atelectasis through the use of high flow nasal cannula versus a high concentration mask for pediatric anesthesia during MRI.
The studied population is all the children between 6 months and 5 years with a pediatric indication of general anesthesia for MRI.
The primary goal is to show a reduction of volume (cm3) of the atelectasis via the application of a PEP by high flow nasal cannula.
The main assessment criteria is the ratio of atelectasis volume/total lung volume.
The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software. The duration of the examination and the anesthesia is slighty lengthened, 3 to 5 minutes for a 40 minutes' exam.
The secondary objective is to show a match between the atelectasis on MRI and ultrasound.
Detailed description
Anesthesia causes respiratory changes and complications, which are the main causes of complications and anesthesia-related deaths.
Among the complications, the rapid appearance of lung atelectasis is well known, deteriorating the hematosis during anesthesia, and inducing secondary pulmonary complications.
Prevention or limitation of the atelectasis would be a way to improve the safety of patients who have a limited respiratory function.
The application of a positive expiratory pressure (PEP) is an effective prevention method for atelectasis, that has been demonstrated only in patients under mechanical ventilation.
The high flow nasal cannula is a non-invasive technique easy to perform and allowing a PEP. High flow nasal cannula is safe to use, and the interface is free from local skin complications.
Chest X-ray (bad sensibility) or CT are usually used for the diagnosis of atelectasis, but these two exams involve irradiation for patient. MRI and pulmonary ultrasonography has now been validated in adults. The investigators has a long experience of anesthesia in spontaneous ventilation in children for MRI. MRI are relatively long, and allow to investigate the atelectasis with only a short additional acquisition time.
Thus, it would be the first study on the effect of the PEP on the impact and the volume of the atelectasis during general anesthesia in spontaneous ventilation in children. By the way this is the first study on lung's anatomical effects of high flow nasal cannula.
It is a monocentric, intervention, randomized, superiority study whose main purpose is to show the reduction of the atelectasis through the use of high flow nasal cannula versus a high concentration mask for pediatric anesthesia during MRI.
The studied population is all the children between 6 months and 5 years with a pediatric indication of general anesthesia for MRI.
The primary goal is to show a reduction of volume (cm3) of the atelectasis via the application of a PEP by high flow nasal cannula.
The main assessment criteria is the ratio of atelectasis volume/total lung volume.
The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software. The duration of the examination and the anesthesia is slighty lengthened, 3 to 5 minutes for a 40 minutes' exam.
The secondary objective is to show a match between the atelectasis on MRI and ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –standard general anesthesia using sevoflurane delivered by a pediatric high concentration mask |
| Intervention group | Experimental | Device: high flow nasal canulasevoflurane will be deliver by a pediatric high flow nasal canula (2L/KG/min) |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Indication of general anesthesia for MRI
- Patient between 6 months and 5 years old
- ASA score I or II
- No facial dysmorphia
- No predicting difficult intubation
Key exclusion criteria (4 listed)
- Severe cardio-pulmonary disease
- Lack of coverage by health insurance
- ASA III or IV
- Parental refuse for inclusion
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 |
|---|---|---|
| high flow nasal canulahigh flow nasal canula to obtain a positive expiratory pressure | Device | Intervention group |
Primary outcome
atelectasis volume by Lung MRI
Time frame: 40 minutes
volume (cm3) of the total lung. The main assessment criteria is the ratio of atelectasis volume/total lung volume. The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software.
total lung volume by Lung MRI
Time frame: 40 minutes
volume (cm3) of the atelectasis via the application of a PEP by high flow nasal cannula. The main assessment criteria is the ratio of atelectasis volume/total lung volume. The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software.
1 secondary outcome
atelectasis volume by lung ultrasonography
Time frame: 15 to 45 minutes after begining general anesthesia
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 4 Jun 2024.
- Derived from this study: PubMed 33080406Roncin C, Scemama U, Zieleskiewicz L, Loundou A, Lesavre N, Vialet R. Atelectasis prevention during anaesthesia using high-flow nasal cannula therapy: A paediatric randomised trial using MRI images. Anaesth Crit Care Pain Med. 2020 Dec;39(6):819-824. doi: 10.1016/j.accpm.2020.08.009. Epub 2020 Oct 17.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal canula in people with Atelectasis, run by Assistance Publique Hopitaux De Marseille 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 6 inclusion and 4 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 4 Jun 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?
atelectasis volume by Lung MRI (time frame: 40 minutes). The study lists 2 primary outcomes in all. 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 NCT03592589, 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 4 Jun 2024.