Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia in Children (PREVAT-PED)
Primary Purpose
Atelectasis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high flow nasal canula
Sponsored by
About this trial
This is an interventional treatment trial for Atelectasis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe cardio-pulmonary disease
- Lack of coverage by health insurance
- ASA III or IV
- Parental refuse for inclusion
Sites / Locations
- Assistance Publique Des Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
Intervention group
Arm Description
standard general anesthesia using sevoflurane delivered by a pediatric high concentration mask
sevoflurane will be deliver by a pediatric high flow nasal canula (2L/KG/min)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
atelectasis volume by lung ultrasonography
Lung ultrasonography will be pratice in recovery room, just after the MRI. The Lung ultrasonography score will be collected.
Full Information
NCT ID
NCT03592589
First Posted
June 26, 2018
Last Updated
February 21, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03592589
Brief Title
Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia in Children
Acronym
PREVAT-PED
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
February 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
standard general anesthesia using sevoflurane delivered by a pediatric high concentration mask
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
sevoflurane will be deliver by a pediatric high flow nasal canula (2L/KG/min)
Intervention Type
Device
Intervention Name(s)
high flow nasal canula
Intervention Description
high flow nasal canula to obtain a positive expiratory pressure
Primary Outcome Measure Information:
Title
atelectasis volume by Lung MRI
Description
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.
Time Frame
40 minutes
Title
total lung volume by Lung MRI
Description
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.
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
atelectasis volume by lung ultrasonography
Description
Lung ultrasonography will be pratice in recovery room, just after the MRI. The Lung ultrasonography score will be collected.
Time Frame
15 to 45 minutes after begining general anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Severe cardio-pulmonary disease
Lack of coverage by health insurance
ASA III or IV
Parental refuse for inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE GARRIDO PRADALIE
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Des Hopitaux de Marseille
City
Marseille
State/Province
Paca
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33080406
Citation
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.
Results Reference
derived
Learn more about this trial
Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia in Children
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