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Prospective Evaluation of Needle Exsufflation for Pneumothorax

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ClinicalTrials.gov Identifier: NCT02528734
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Prof Jean-Damien RICARD, Hôpital Louis Mourier

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

Condition or disease
Pneumothorax

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).

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Pneumothorax Duration Before Treatment on the Success of Needle Exsufflation
Actual Study Start Date : January 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients admitted to the ICU with a pneumothorax
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528734


Locations
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France
Louis Mourier Hospital
Colombes, France, 92700
Sponsors and Collaborators
Hôpital Louis Mourier
Investigators
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Study Director: Ricard Jean-Damien, MD, PhD Hopital Louis Mourier
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof Jean-Damien RICARD, Professor in Intensive Care Medicine, Assistant Head of Medico-Surgical ICU, Hôpital Louis Mourier
ClinicalTrials.gov Identifier: NCT02528734    
Other Study ID Numbers: HLM_JDR5
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Keywords provided by Prof Jean-Damien RICARD, Hôpital Louis Mourier:
pneumothorax
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases