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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT05693051

Collaborator

Aarhus University Hospital (Other)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
ARDS, Human Extracorporeal Membrane Oxygenation COVID-19 Acute Respiratory Distress Syndrome Prone Position Adverse Event	Other: Prone position ventilation

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

68 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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)

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Nov 1, 2022

Actual Study Completion Date :

Nov 1, 2022

Outcome Measures

Primary Outcome Measures

90 day mortality [90 days]
all cause mortality 90 days after ECMO start

Secondary Outcome Measures

Time-to-wean [From start of ECMO treatment to succesful weaning from ECMO]
Time from ECMO start to succesful weaning from ECMO
Recruitment Response to prone position ventilation [from prone position start to prone position end]
lung recruitment
Oxygenation Response to prone position ventilation [from prone position start to prone position end]
Oxygenation

Other Outcome Measures

Adverse Events [From ECMO start to ECMO end (all causes)]
Number and nature of adverse events related to prone position ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital, CardioThoracic Intensive care Unit	Aarhus		Denmark	8200
2	University Hospital Rigshospitalet, department of CardioThoracic Anaesthesia and Intensive Care	Copenhagen		Denmark	2100