Prospective Evaluation of Needle Exsufflation for Pneumothorax

Completed

• Conditions: Pneumothorax

• Registration Number: NCT02528734
• Lead Sponsor: Hôpital Louis Mourier

Brief Summary

Monocentric observational study of needle exsufflation for pneumothorax in the ICU.

Detailed Description

The main objective of this prospective observational non interventional study is to investigate a possible relationship between prior duration of pneumothorax (defined as the duration from first occurence of chest pain reported by patient to exsufflation) and the success of exsufflation procedure (defined by the absence of a chest tube insertion in the following 24h).

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• adult ICU patients requiring needle exsufflation for spontaneous pneumothorax

Exclusion Criteria

• refuse to participate
• contraindications to needle exsufflation (acute respiratory failure requiring immediate chest tube insertion)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with early success of needle exsufflation with duration of symptoms prior to exsufflation greater than 48 hrs	24 hrs	success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation; duration of symptoms prior to exsufflation is the time (in hrs) elapsed between first chest pain reported by the patient and needle exsufflation
Number of patients with early success of needle exsufflation	24 hrs	success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation

Secondary Outcome Measures

Name	Time	Method
Number of patients requiring early surgical pleurodesis because of persistent pneumothorax	8 days	Patients will be monitored for eventual need for surgical pleurodesis during their ICU stay because of persistent or worsening pneumothorax
Number of patients with late exsufflation failure	8 days	late exsufflation failure is defined as patients requiring chest tube insertion at least 24 hrs after needle exsufflation because of persistent or worsening of pneumothorax despite initial early success
Length of ICU stay	8 days	participants will be followed for the duration of ICU stay, from ICU admission to ICU discharge, an expected average of 8 days
Length of hospital stay	15 days	participants will be followed for the duration of hospital stay, from hospital admission to hospital discharge, an expected average of 15 days

Trial Locations

Locations (1)

Louis Mourier Hospital; 🇫🇷 Colombes, France