Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO

ARDS, Human Clinical Trial

Official title:

Use of Prone Position Ventilation (PPV) in Danish Patients With COVID-19 Induced Severe Adult Respiratory Distress Syndrome (ARDS) Treated With Veno-Venous Extracorporeal Membrane Oxygenation (VV-ECMO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05693051
• Other study ID #: 20049299-PPV
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19 induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the incidence of PPV related adverse events was high

Description:

Purpose: To describe the use and effects of prone position ventilation (PPV) in patients with COVID-19 induced Adult Respiratory Distress Syndrome (ARDS), treated with Veno-Venous Extracorporeal membrane oxygenation (VV-ECMO). Methods: Nationwide retrospective analysis of all COVID-19 patients in Denmark from March 2020 - December 2021with severe ARDS and need of VV-ECMO treatment. Data on the number of patients treated with PPV, number of PPV-events, timing, the time spent in prone position, physiological response types, adverse events and outcomes are reported.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria: patients with COVID-19 induced severe ARDS accepted for and treated with VV-ECMO in Denmark -

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Acute Lung Injury
• Adverse Event
• ARDS, Human
• COVID-19
• Extracorporeal Membrane Oxygenation
• Prone Position
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• Prone position ventilation
Turning the patient prone for 16 hours

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, CardioThoracic Intensive care Unit	Aarhus
Denmark	University Hospital Rigshospitalet, department of CardioThoracic Anaesthesia and Intensive Care	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Number and nature of adverse events related to prone position ventilation	From ECMO start to ECMO end (all causes)
Primary	90 day mortality	all cause mortality 90 days after ECMO start	90 days
Secondary	Time-to-wean	Time from ECMO start to succesful weaning from ECMO	From start of ECMO treatment to succesful weaning from ECMO
Secondary	Recruitment Response to prone position ventilation	lung recruitment	from prone position start to prone position end
Secondary	Oxygenation Response to prone position ventilation	Oxygenation	from prone position start to prone position end