Prone Duration in COVID-19 ARDS

NCT06765759 | Completed

• 1 other identifier: 2023/789
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to learn the effects of prone position duration on patient outcomes in patients with severe acute respiratory distress syndrome (ARDS) due to Coronavirus Disease - 2019 (COVID-19). The main question it aims to answer is: Does the length of prone position duration affect gas exchange in patients with severe ARDS and is there a difference between genders in this regard? The differences in gas exchange between those who have been in prone position for 16-24 hours and those who have been in prone position for 24-36 hours as part of severe ARDS treatment will be examined.

Conditions

COVID - 19; Acute Respiratory Distress Syndrome (ARDS)

Keywords

COVID - 19; Acute Respiratory Distress Syndrome; Prone Position; Sex

Outcome Measures

Primary Outcomes (1)

• Calculation of PaO2/FiO2 ratio during short and long prone periods

  Partial arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2) ratio changes before, during and after pronation at each group will be calculated.

  At each prone session, calculation will be started one hour before the pronation and finished one hour after returning supine.

Secondary Outcomes (2)

• Measurement of PaCO2 during short and long prone periods

  At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.

• Measurement of PEEP during short and long prone periods

  At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.

Study Arms (2)

Short Prone

The group of patients who remained in prone position for 16-24 hours

Long Prone

The group of patients who remained in prone position for 24-36 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of Covid-19 ARDS patients hospitalized in the tertiary intensive care unit of a university hospital.

You may qualify if:

• \>18 years old
• hospitalized for more than 48 hours
• patients diagnosed with COVID-19
• intubated patients
• underwent prone positioning for longer than 16 hours starting from the first session

You may not qualify if:

• Pregnant females
• Patients under the age of 18
• Those who did not reach 16 hours duration of prone position for various reasons (unintentional extubation, ventilation problems, hemodynamic instability, cardiac arrest-prearrest)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty

Istanbul, 34153, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Coitus

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Sexual Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: January 1, 2024
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)