Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (Other)
Overall Status
Completed
CT.gov ID
NCT04840953
Collaborator
(none)
2
1
2
1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
2 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients
Actual Study Start Date
:
Dec 1, 2020
Actual Primary Completion Date
:
Jan 1, 2021
Actual Study Completion Date
:
Feb 1, 2021
Outcome Measures
Primary Outcome Measures
- Resolution time of emphysema with negative pressure therapy [Days]
Days
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Subcutaneous emphysema that compromises ventilation
Exclusion Criteria:
- Declined Therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital General Universitario de Elche | Elche | Alicante | Spain | 03203 |
Sponsors and Collaborators
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Luis Sánchez Guillen,
Colorrectal Surgeon,
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier:
NCT04840953
Other Study ID Numbers:
- ENFIVAC
First Posted:
Apr 12, 2021
Last Update Posted:
Apr 12, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: