Pneumothorax
Conditions
Keywords
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).
Interventions
None listed
Sponsors
Hôpital Louis Mourier
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with early success of needle exsufflation | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 15 days | participants will be followed for the duration of hospital stay, from hospital admission to hospital discharge, an expected average of 15 days |
| Length of ICU stay | 8 days | participants will be followed for the duration of ICU stay, from ICU admission to ICU discharge, an expected average of 8 days |
| Number of patients requiring early surgical pleurodesis because of persistent pneumothorax | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximal patient self-reported pain during procedure | 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 \[worst possible pain\] |
| Number of patients with pneumothorax recurrence | 30 days | Patients will be followed for an expected average of 30 days to identify those with recurrent pneumothorax |
| Number of patients with treatment-related adverse event | 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) |
Countries
France
Outcome results
None listed