Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients

Completed

• Conditions: Subcutaneous Emphysema; Covid19

• Registration Number: NCT04840953
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Brief Summary

Background Numerous surgicals treatments have been described for the massive subcutaneous emphysema; however, some of these techniques cannot be carried out in a critical care unit and they are related with high morbidity and exposure in positive SARS COV-2 patients. More effective, less invasive and isolated procedures should be implemented.

Technique Negative pressure therapy (NPT) that can allow effective solving of massive subcutaneous emphysema in a short period (5 days) with a minimally invasive approach at the bedside in Covid-19 or non infected critical patients.

Conclusion NPT is an effective and low invasive strategy for the management of EES in critical patients with high risk of mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-12
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Subcutaneous emphysema that compromises ventilation

Exclusion Criteria

• Declined Therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resolution time of emphysema with negative pressure therapy	Days	Days

Trial Locations

Locations (1)

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain