Initial management of well tolerated but voluminous primary pneumothorax : intercostal chest tube versus needle aspiration.

Study PRotocol for the INitial management of well toleraTED but voluminous primary pneumothorax

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202002728476768

Enrollment

100

Registered

2020-02-26

Start date

2020-02-01

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory

Interventions

needle aspiration group

chest tube

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: age above eighteen years old normal neurological state written informed consent First episode of large pneumothorax defined by a volume surpassing 41% of thoracic volume, which correspond to an interpleural distance over 8 cm according to Collins Formula. No radiological sign of an underlying pulmonary disease No signs of a non tolerated pneumothorax

Exclusion criteria

Exclusion criteria: Past medical history of pneumothorax Radiological sign of secondary pneumothorax Hydropneumothorax Bilateral pneumothorax clinical signs of a non tolerated pneumothorax : oxymetry< 90% , schock index PAS/FC < 1 HIV infection impossibility to consent due to mental impairement incarceration

Design outcomes

Primary

Measure	Time frame
Success rate 5 days after procedure of pneumothorax evacuation - Success for manual aspiration was defined as complete or nearly complete and persistent lung expansion. Tolerated interpleural distance in the apex is less than 1 cm - Success for chest tube drainage was defined as complete lung expansion, absence of air leakage , and soft aspiration removal within 5 days after tube placement - ;recurrence rate over one year of follow up	—

Measure

Time frame

Success rate 5 days after procedure of pneumothorax evacuation - Success for manual aspiration was defined as complete or nearly complete and persistent lung expansion. Tolerated interpleural distance in the apex is less than 1 cm - Success for chest tube drainage was defined as complete lung expansion, absence of air leakage , and soft aspiration removal within 5 days after tube placement - ;recurrence rate over one year of follow up

—

Secondary

Measure	Time frame
Immediate success rate after procedure of pneumothorax evacuation - Immediate success for manual aspiration was defined as complete or nearly complete and persistent lung expansion immediately following manual aspiration. - Immediate success for chest tube drainage was defined as complete lung expansion, absence of air leakage in less than 48 hours after tube placement - ;need for pleurodesis in case of persistence of pneumothorax;Hospitalization duration	—

Measure

Time frame

Immediate success rate after procedure of pneumothorax evacuation - Immediate success for manual aspiration was defined as complete or nearly complete and persistent lung expansion immediately following manual aspiration. - Immediate success for chest tube drainage was defined as complete lung expansion, absence of air leakage in less than 48 hours after tube placement - ;need for pleurodesis in case of persistence of pneumothorax;Hospitalization duration

—

Countries

Tunisia

Contacts

Public Contactsoraya fenniche

Service de pneumologie Pavillon 4 Hopital A Mami

soraya.fenniche@yahoo.fr+21698586490

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026