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Comparison of the Outcome of Using One-way Heimlich Valve in the Treatment of Primary Spontaneous Pneumothorax in Comparison with Implantation of Chest Tube and Connection to the Bottle

Comparison of the Outcome of Using One-way Heimlich Valve in the Treatment of Primary Spontaneous Pneumothorax in Comparison with Implantation of Chest Tube and Connection to the Bottle, A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230208057359N1
Enrollment
40
Registered
2023-02-13
Start date
2023-03-21
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Primary Spontaneous Pneumothorax. Primary spontaneous pneumothorax

Interventions

Intervention 1: For the participants in the first intervention group, chest tube number 28 will be inserted from the fourth or fifth intercostal space in the area of ??the anterior to mid-axillary lin

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 40 years old with Primary Spontaneous Pneumothorax that is symptomatic and the lung collapse rate is more than 15% (the distance between the chest wall and the lung is more than 1 cm) No history of trauma in the last month No history of severe asthma or chronic obstructive pulmonary disease Not suffering from psychosis Do not require special medical services such as hospitalization in ICU Do not have complete lung collapse Not breastfeeding or pregnant

Exclusion criteria

Exclusion criteria: Patients who are eligible to enter the study but did not consent to enter the study Patients who developed complications and the patient's treatment was discontinued Patients in need of Video-assisted thoracoscopic surgery include having one lung, being a diver or a pilot, having a large Pulmonary Embolus Treatment failure after 7 days

Design outcomes

Primary

MeasureTime frame
The hospitalization duration from the start of treatment until the time of removal of the chest tube. Timepoint: When the chest tube is removed, the hospitalization duration is calculated. Method of measurement: Days recorded in the patient's file.

Secondary

MeasureTime frame
Pain Severity. Timepoint: Daily examination during hospitalization and weekly after discharge for up to 4 weeks. Method of measurement: Visual Analogue Scale score (0 to 10).;Readmission. Timepoint: Weekly from the time of discharge up to 4 weeks. Method of measurement: Based on examinations, symptoms and paraclinical measures.;Treatment failure. Timepoint: 7 days after the intervention. Method of measurement: No symptom improvement or incomplete opening of the lung after 7 days is considered as treatment failure.;Complications. Timepoint: Daily examination during hospitalization and weekly after discharge for up to 4 weeks. Method of measurement: Occurrence of complications including subcutaneous Emphysema, Hematoma and wound infection through examination and clinical symptoms.;Shortness of breath severity. Timepoint: Daily examination during hospitalization and weekly after discharge for up to 4 weeks. Method of measurement: Visual Analogue Scale score (0 to 10).;Ketorolac injection. Timepoint: Daily examination during hospitalization. Method of measurement: The number of requests and the milligrams of the injected Ketorolac.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohammad Naghibalghora Banadaki

Karaj University of Medical Sciences

m.naghib@abzums.ac.ir+98 26 3442 7001

Outcome results

None listed

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