Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography

Completed

• Conditions: Intubation, Intratracheal

• Registration Number: NCT02822846
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe.

The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently :

* sonography

* chest radiography

A correct position of the intubation probe will be considered if there is :

* Highlighting of the extremity of the intubation probe in endo tracheal

* Highlighting bilateral lung sliding

Detailed Description

Oesophageal intubation can cause death. Selective intubation can induce a poor ventilation, hypoxemia, atelectasis etc... It's not rare in paediatric intubation. The prevalence of malposition of endotracheal tube is 30 to 40% in babies and infants less than 1 year old. Currently doctors try to detect malposition of intra-tracheal tube by auscultation and capnograms and chest radiography is needed to confirm it. The Chest X ray is the gold standard.

The aim of the study is to confirm the good positioning of the tube with a lung ultrasonography.

After each intra-tracheal intubation, for patients with qualifying criteria, a lung ultrasonography will be performed, in bed, by two trained doctors (senior and junior) to determine if the position is right. Then, the chest radiography will be performed as usual.

Study Timeline

• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-04
• Study Start: 2016-11-19
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2020-01
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Patient less than 18 years old
• Patient intubated and ventilated
• intubation probe considered in place on auscultation
• SpO2> 92%
• Affiliate or entitled to a social security scheme
• No opposition of any of the parents.

Exclusion Criteria

• Children too unstable : decompensated shock
• Spontaneous pneumothorax
• Heart massage ongoing
• Chest trauma
• Faulty position of the probe intubation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the position of intubation probe by comparison between chest radiography and lung ultrasonography	day of enrollment	correct position is defined by : * visualization of the probe intubation extremity in endotracheal; * visualization of bilateral lung sliding

Secondary Outcome Measures

Name	Time	Method
Number of malpositions of the intubation probe evaluated with lung ultrasonography by senior evaluator	day of enrollment
Number of mobilized intubation probes	day of enrollment	Due to inefficient ventilation and despite undetected malposition
Number of malpositions of the intubation probe evaluated with lung ultrasonography by junior evaluator	day of enrollment
Number of patients with malposition of the oesophageal or selective intubation probe	day of enrollment
Number of malpositions of the intubation probe evaluated with a chest radiography by junior evaluator	day of enrollment
Number of malpositions of the intubation probe evaluated with a chest radiography by senior evaluator	day of enrollment

Trial Locations

Locations (1)

Intensive Care Unit of Necker Hospital; 🇫🇷 Paris, France