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

NCT04840953 | Completed DMC

• 1 other identifier: ENFIVAC
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Resolution time of emphysema with negative pressure therapy

  Days

  Days

Interventions

Vçac DEVICE

VAC THERAPY vs SURGICAL DREINAGE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subcutaneous emphysema that compromises ventilation with or not SARS COV2 infection

You may qualify if:

• Subcutaneous emphysema that compromises ventilation

You may not qualify if:

• Declined Therapy

Sponsors & Collaborators

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

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Subcutaneous Emphysema; COVID-19

Condition Hierarchy (Ancestors)

Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorrectal Surgeon

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: December 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)