A trial of suction for the early resolution of a collapsed lung

Not Applicable

• Conditions: Primary spontaneous pneumothorax; Respiratory

• Registration Number: ISRCTN18017504
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-07
• Last Update Posted: 18 March 2024
• Study Completion: 2027-02-27

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Participants with primary spontaneous pneumothorax (PSP) (either first or recurrent episode)
2. Male and Female aged 16* to 50 years old
3. Pneumothorax requiring chest drain in hospital (ideally within 24 hours of drain insertion, but up to 72 hours))
4. Willing and able to give written consent
5. Access to an electronic device for questionnaire completion

*Common law presumes that young people aged between 16 and 18 years old are usually competent to give consent to treatment and consent from those with parental responsibility is not legally necessary. Eligible young persons believed to be competent by the PI or delegate should be approached about the study. The involvement of parents in decision-making should be encouraged unless the young person objects.

Exclusion Criteria

1. Known or suspected underlying lung disease**. This does not include the presence of blebs/bullae on CT chest in the absence of another specific respiratory diagnosis
2. Inability to consent or comply with trial requirements
3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant’s ability to participate in the study.

**Childhood asthma” is not considered an exclusion criterion. Patients with a diagnosis of asthma in childhood/young adulthood who do not require the use of a regular preventer” inhaler (i.e. inhaler containing a steroid or long-acting beta-agonist), and only occasionally use a reliever” inhaler (short-acting beta-agonist) and have never been hospitalised due to asthma remain eligible for participation in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total treatment duration, defined as the time from randomisation to completion of pleural treatment (including surgery, if required), measured using data recorded in patient medical notes at the completion of treatment (discharge home from hospital with no drain in place)

Secondary Outcome Measures

Name	Time	Method
Outcomes measured using data recorded in patient medical notes:<br>1.1. In-patient surgical rates at the completion of treatment<br>1.2. Length of hospital stay over first the 30 days post-randomisation (including readmissions) at 30 days post-randomisation<br>1.3. Pain and breathless scores (100mm Visual Analogue Scale (VAS)) at baseline, daily until completion of treatment, and at follow-14 days after the completion of treatment and 30 days post-randomisation)<br>1.4. EQ5D at baseline, Completion of treatment, 30 days and 6 months post-randomisation<br>1.5. Rate of recurrence of pneumothorax at 6 months post-randomisation<br><br>2. Incremental cost per quality-adjusted life years (QALYs) gained at randomisation to 6 months measured using data gathered between those timepoints<br><br>3.1. Complication rates at the completion of treatment<br>3.2. Overall number of in-patient pleural procedures at the completion of treatment<br>3.3. Adverse events related to the use of suction at the completion of treatment