Prospective Evaluation of Needle Exsufflation for Pneumothorax

Pneumothorax Clinical Trial

Official title:

Impact of Pneumothorax Duration Before Treatment on the Success of Needle Exsufflation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528734
• Other study ID #: HLM_JDR5
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: September 19, 2017
• Start date: January 2012
• Est. completion date: November 2016

Study information

• Verified date: September 2017
• Source: Hôpital Louis Mourier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pneumothorax

Locations

Country	Name	City	State
France	Louis Mourier Hospital	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Louis Mourier

Country where clinical trial is conducted

France, 

References & Publications (2)

Andrivet P, Djedaini K, Teboul JL, Brochard L, Dreyfuss D. Spontaneous pneumothorax. Comparison of thoracic drainage vs immediate or delayed needle aspiration. Chest. 1995 Aug;108(2):335-9. — View Citation

MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with pneumothorax recurrence	Patients will be followed for an expected average of 30 days to identify those with recurrent pneumothorax	30 days
Other	Maximal patient self-reported pain during procedure	patients are asked to assess the maximal pain felt during needle exsufflation or chest tube insertion with the use of a numeric scale from 0 [no pain] to 10 [worst possible pain]	30 mintutes
Other	Number of patients with treatment-related adverse event	Patients will be followed for 8 days to identify those with either hemothorax (defined as hematic pleural effusion requiring thoracic drainage); or a vacuo pulmonary edema (defined as occurrence of localised alveolar interstitial opacities on post-procedure chest X-ray); or site of chest tube insertion infection (presence of purulent secretions issuing from chest tube insertion site)	8 days
Primary	Number of patients with early success of needle exsufflation	success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation	24 hrs
Primary	Number of patients with early success of needle exsufflation with duration of symptoms prior to exsufflation greater than 48 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	24 hrs
Secondary	Length of ICU stay	participants will be followed for the duration of ICU stay, from ICU admission to ICU discharge, an expected average of 8 days	8 days
Secondary	Length of hospital stay	participants will be followed for the duration of hospital stay, from hospital admission to hospital discharge, an expected average of 15 days	15 days
Secondary	Number of patients requiring early surgical pleurodesis because of persistent pneumothorax	Patients will be monitored for eventual need for surgical pleurodesis during their ICU stay because of persistent or worsening pneumothorax	8 days
Secondary	Number of patients with late exsufflation failure	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	8 days