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Clinical Trials/NCT04818164
NCT04818164
Completed
Not Applicable

Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Associated Acute Respiratory Distress Syndrome: An Observational Study

Istanbul University - Cerrahpasa (IUC)1 site in 1 country43 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
43
Locations
1
Primary Endpoint
Partial Pressure of Oxygen/ Fraction of Inspired Oxygen
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Covid-19 associated Acute Respiratory Distress Syndrome (ARDS) may present with profound hypoxemia not fully explained with pulmonary infiltrates. Accordingly, how prone positioning improves oxygenation in these patients is not fully known. The investigators conducted a study among patients with severe Covid-19 ARDS receiving prone position for at least 16 hours. End Expiratory Lung Volume (EELV) was measured with Nitrogen wash-in/wash-out technique before (Supine Position 1- SP1), during (Prone Position - PP) and after (Supine Position 2 - SP2) prone positioning.

Detailed Description

After initiation of invasive mechanical ventilation, initial ventilator settings were performed by the attending physician. These settings include titration of best PEEP to promote oxygenation if Spo2 \<92% despite a Fio2 higher than 80% or best compliance that do not jeopardize oxygenation if Fio2 is between 50-80% and Spo2 \>92%. After a period of 30 minutes for stabilisation, the first set of measurements were done in the SP1 position. Afterwards, the patient was turned to prone position with the same PEEP (which was unchanged throughout the study period) and measurements were repeated every four hours until the patient was reverted back to SP2. Eventually, there were 7 measurements in total. (SP1, PP0, PP4, PP8, PP12, PP16, SP2). Dead space ventilation and shunt fraction calculations were made based on central venous blood gas measurements and oxygen consumption and carbon dioxide production at the relevant timepoint.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
March 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Olcay Dilken

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Patients were considered eligible if they met the Berlin definition criteria for ARDS and intubated due to increased work of breathing and/or worsening hypoxemia. All patients had a positive Covid-19 real time Polymerase Chain Reaction test

Exclusion Criteria

  • Exclusion criteria were; age \< 18 years, ARDS resulting from other risk factors, presence of chest drainage tubes, tracheostomy, pneumomediastinum, hemodynamic instability (systolic blood pressure \< 100 mmHg, lactate \> 2 mmol/l, or an increase in lactate concentrations for 20% in two consecutive blood gas analysis within 2 hours interval) and suspicion or confirmed pulmonary emboli.

Outcomes

Primary Outcomes

Partial Pressure of Oxygen/ Fraction of Inspired Oxygen

Time Frame: 1 day

Oxygenation

End Expiratory Lung Volume

Time Frame: 1 day

Oxygenation

Secondary Outcomes

  • Dead Space Ventilation(1 day)
  • Lung Compliance(1 day)

Study Sites (1)

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