Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome

• ClinicalTrials.gov Identifier: NCT04818164
• Recruitment Status: Completed
• First Posted: March 26, 2021
• Last Update Posted: March 4, 2022
• Sponsor: Istanbul University-Cerrahpasa
• Information provided by (Responsible Party): Olcay Dilken, Istanbul University-Cerrahpasa

Study Description

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.

Condition or disease
Acute Respiratory Distress Syndrome; Coronavirus; Mechanical Ventilation Complication; Ventilation Perfusion Mismatch

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Associated Acute Respiratory Distress Syndrome: An Observational Study
• Actual Study Start Date: September 1, 2020
• Actual Primary Completion Date: September 30, 2021
• Actual Study Completion Date: March 1, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Partial Pressure of Oxygen/ Fraction of Inspired Oxygen [ Time Frame: 1 day ]
   Oxygenation
2. End Expiratory Lung Volume [ Time Frame: 1 day ]
   Oxygenation

Secondary Outcome Measures :

1. Lung Compliance [ Time Frame: 1 day ]
   Change in Recruitable Lung Volume
2. Dead Space Ventilation [ Time Frame: 1 day ]
   Fraction of Wasted Ventilation

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Adult Patients receiving invasive mechanic ventilation due to Covid-19 ARDS

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.

Contacts and Locations

Locations

Turkey

Istanbul University-Cerrahpaşa

Istanbul, Turkey

Sponsors and Collaborators

Istanbul University-Cerrahpasa

Investigators

• Principal Investigator: Olcay Dilken, Dr.; Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

More Information

• Responsible Party: Olcay Dilken, Principal Investigator, Istanbul University-Cerrahpasa
• ClinicalTrials.gov Identifier: NCT04818164
• Other Study ID Numbers: 2020-19-16163
• First Posted: March 26, 2021
• Last Update Posted: March 4, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Olcay Dilken, Istanbul University-Cerrahpasa:

acute respiratory distress syndrome; prone position; lung recruitment

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Disease; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury