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

NCT ID: NCT04840953

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-02-01

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.

Conditions

Subcutaneous Emphysema; Covid19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Vçac

VAC THERAPY vs SURGICAL DREINAGE

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subcutaneous emphysema that compromises ventilation

Exclusion Criteria

• Declined Therapy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role: lead

Responsible Party

Luis Sánchez Guillen

Colorrectal Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital General Universitario de Elche

Elche, Alicante, Spain

Countries

Spain

Other Identifiers

ENFIVAC

Identifier Type: -

Identifier Source: org_study_id