Clinical trial NCT02528734: Prospective Evaluation of Needle Exsufflation for Pneumothorax
Official title: Impact of Pneumothorax Duration Before Treatment on the Success of Needle Exsufflation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumothorax
Keywords: pneumothorax
Lead sponsor: Hôpital Louis Mourier
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients admitted to the ICU with a pneumothorax

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

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).

Eligibility 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)

Primary outcomes:
measure: Number of patients with early success of needle exsufflation
timeFrame: 24 hrs
measure: Number of patients with early success of needle exsufflation with duration of symptoms prior to exsufflation greater than 48 hrs
timeFrame: 24 hrs
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 8 days
measure: Length of hospital stay
timeFrame: 15 days
measure: Number of patients requiring early surgical pleurodesis because of persistent pneumothorax
timeFrame: 8 days
measure: Number of patients with late exsufflation failure
timeFrame: 8 days
Other outcomes:
measure: Number of patients with pneumothorax recurrence
timeFrame: 30 days
measure: Maximal patient self-reported pain during procedure
timeFrame: 30 mintutes
measure: Number of patients with treatment-related adverse event
timeFrame: 8 days
Locations:
city: Colombes
country: France
facility: Louis Mourier Hospital
Study officials:
affiliation: Hopital Louis Mourier
name: Ricard Jean-Damien, MD, PhD
role: STUDY_DIRECTOR
References:
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. No abstract available.
citation: 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.
citation: 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.