Respiratory Failure Clinical Trial
Official title:
Safety and Feasibility of Percutaneous Dilatational Tracheostomy in Patients With Severe COVID-19 Disease Supported by Extracorporeal Membrane Oxygenation.
Verified date | August 2021 |
Source | Hamad Medical Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
COVID-19 pandemic has presented the global health care systems with unprecedented and unexpected challenges. The clinical spectrum of COVID-19 disease varies from mild, at times asymptomatic, to severe life-threatening multiple organ dysfunction and shock. The latter group, albeit represent less than 10% of all SARS-CoV-2 infections will require ICU admission, multi-modal organ support including Extracorporeal Membrane Oxygenation (ECMO) for severe refractory cardiac and/or pulmonary failure. Prolonged mechanical ventilation is a typical indication for tracheostomy. Percutaneous tracheostomy at the bedside has several advantages over surgical tracheostomy. However, with the emerging pandemic, there is a lack of literature regarding the safety of percutaneous bedside tracheostomy for patients with COVID-19 supported by ECMO. Our study aims to describe the safety of bedside percutaneous dilatational tracheostomy of confirmed COVID-19 positive patients supported on ECMO.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 1, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - over 18-years old. Exclusion Criteria: - less than 18 years old, - Pregnancy - VA-ECMO |
Country | Name | City | State |
---|---|---|---|
Qatar | Hamad Medical Corporation | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation |
Qatar,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | External or endotracheal bleeding (mild, moderate, sever) | Mild: Minimal external or endotracheal bleeding with minimal or no drop-in haemoglobin and no surgical intervention.
Moderate: Obvious external or endotracheal bleed. A drop-in haemoglobin of less than one gram/dL or transfusion of one unit of red blood cells. Severe bleeding: a drop of two grams or more in haemoglobin/dL and/or transfusion of two or more red cell packs or other blood products, disseminated intravascular coagulopathy (DIC) or need for surgical intervention |
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