NCT02528734

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

4.3 years

First QC Date

August 17, 2015

Last Update Submit

September 19, 2017

Conditions

Pneumothorax

Keywords

pneumothorax

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Length of ICU stay

    8 days

  • Length of hospital stay

    15 days

  • Number of patients requiring early surgical pleurodesis because of persistent pneumothorax

    8 days

  • Number of patients with late exsufflation failure

    8 days

Other Outcomes (3)

  • Number of patients with pneumothorax recurrence

    30 days

  • Maximal patient self-reported pain during procedure

    30 mintutes

  • Number of patients with treatment-related adverse event

    8 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients admitted to the ICU with a pneumothorax

You may qualify if:

  • adult ICU patients requiring needle exsufflation for spontaneous pneumothorax

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Mourier Hospital

Colombes, 92700, France

Location

Related Publications (3)

  • 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.

    PMID: 20696690BACKGROUND

  • 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.

    PMID: 7634863RESULT

  • Vuillard C, Dib F, Achamlal J, Gaudry S, Roux D, Chemouny M, Javaud N, Dreyfuss D, Ricard JD, Messika J. Longer symptom onset to aspiration time predicts success of needle aspiration in primary spontaneous pneumothorax. Thorax. 2019 Aug;74(8):780-786. doi: 10.1136/thoraxjnl-2019-213168. Epub 2019 Jun 12.

    PMID: 31189731DERIVED

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Ricard Jean-Damien, MD, PhD

    Hopital Louis Mourier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Intensive Care Medicine, Assistant Head of Medico-Surgical ICU

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 19, 2015

Study Start

January 1, 2012

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations

FR(1)