Prospective Evaluation of Needle Exsufflation for Pneumothorax

Overview

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

Full Title of Study: “Impact of Pneumothorax Duration Before Treatment on the Success of Needle Exsufflation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2016

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).

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with early success of needle exsufflation
    • Time Frame: 24 hrs
    • success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation
  • Number of patients with early success of needle exsufflation with duration of symptoms prior to exsufflation greater than 48 hrs
    • Time Frame: 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

Secondary Measures

  • Length of ICU stay
    • Time Frame: 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
    • Time Frame: 15 days
    • participants will be followed for the duration of hospital stay, from hospital admission to hospital discharge, an expected average of 15 days
  • Number of patients requiring early surgical pleurodesis because of persistent pneumothorax
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hôpital Louis Mourier
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof Jean-Damien RICARD, Professor in Intensive Care Medicine, Assistant Head of Medico-Surgical ICU – Hôpital Louis Mourier
  • Overall Official(s)
    • Ricard Jean-Damien, MD, PhD, Study Director, Hopital Louis Mourier

References

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. No abstract available.

Citations Reporting on Results

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. doi: 10.1378/chest.108.2.335.

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