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Completed

NCT Number: NCT02528734

Prospective Evaluation of Needle Exsufflation for Pneumothorax

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Louis Mourier Hospital

Colombes, 92700, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. Number of patients with pneumothorax recurrence

    Time frame: 30 days

    Patients will be followed for an expected average of 30 days to identify those with recurrent pneumothorax

  2. Maximal patient self-reported pain during procedure

    Time frame: 30 mintutes

    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]

  3. Number of patients with treatment-related adverse event

    Time frame: 8 days

    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)

Sponsors and collaborators

Lead sponsor

Hôpital Louis Mourier

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2015
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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