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The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.

NCT05180955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-06-20

No results posted yet for this study

Summary

The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. Primary outcome measure: recurrent pneumothorax after chest tube removal requiring chest tube reinsertion

Conditions

  • Pneumothorax and Air Leak

Interventions

OTHER

Digital drainage system

In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data, the tube will not be clamped.

OTHER

Digital drainage system + clamping trial

In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.

Sponsors & Collaborators

  • Isala

    lead OTHER

Principal Investigators

  • Jos Stigt, MD PhD · Isala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2024-05-29
Completion
2024-05-29

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180955 on ClinicalTrials.gov