Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia in Children

NCT03592589 | Completed

• 1 other identifier: 2017-39
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  40 minutes

Secondary Outcomes (1)

• atelectasis volume by lung ultrasonography

  15 to 45 minutes after begining general anesthesia

Study Arms (2)

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)

Device: high flow nasal canula

Interventions

high flow nasal canula DEVICE

high flow nasal canula to obtain a positive expiratory pressure

Intervention group

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe cardio-pulmonary disease
• Lack of coverage by health insurance
• ASA III or IV

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13005, France

Location

Related Publications (1)

• 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.

  PMID: 33080406 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 19, 2018
• Study Start: October 10, 2018
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

FR (1)