The Effect of Prone Position on Oxygen Saturation, Blood Gas Parameters, and Respiratory Rate in Intensive Care Patients With COVID-19-induced ARDS
Phase: NA
Conditions: COVID - 19, ARDS (Acute Respiratory Distress Syndrome)
Sponsor: Medet Korkmaz

STUDY DOCUMENT
Official Study Title:
The Effect of Prone Position on Oxygen Saturation, Blood Gas Parameters, and Respiratory
Rate in Intensive Care Patients with COVID-19-induced ARDS
NCT Number: NCTXXXXXXXX
Document Type: Study Protocol
Document Date: 26 May 2025

STUDY PROTOCOL
1. Oficial Title
The Effect of Prone Position on Oxygen Saturation, Blood Gas Parameters, and Respiratory
Rate in Intensive Care Patients with COVID-19-induced ARDS
2. Brief Title
Effect of Prone Position in COVID-19 ARDS Patients
3. Principal Investigator(s)
- Dr. Veysel Tekin, RN, Ph.D. – Diyarbakır Provincial Health Directorate
- Prof. Dr. Medet Korkmaz, RN, Ph.D. – Inonu University Faculty of Nursing
4. Study Sites
General and Intermediate Intensive Care Units, Eastern Turkey
5. Study Period
Start Date: April 1, 2021
End Date: August 30, 2021
6. Background and Rationale
ARDS is a common complication of severe COVID-19, associated with high mortality. Prone
positioning has been shown to improve oxygenation and lung compliance in ARDS. This
study investigates its short-term effectiveness in non-intubated patients.
7. Objectives
To evaluate the impact of a 30-minute prone position on:
- Oxygen saturation (SpO₂, SaO₂, PO₂)
- Respiratory rate
- Blood gas parameters (pH, PCO₂, Lactate, Sodium)
8. Study Design
Randomized controlled trial
Parallel group, repeated measures (6 total timepoints)
1:1 allocation (n = 90, 45 per group)
9. Eligibility Criteria
**Inclusion Criteria:**
- Age ≥ 40
- ICU hospitalization for COVID-19-induced ARDS
- Intubated and responsive to assessment
**Exclusion Criteria:**
- Sensory impairments (vision/hearing)

- Cognitive impairments
- Patients who died or no longer required ICU during study
10. Intervention
**Experimental Group:** 30 minutes prone position once daily for 2 days
**Control Group:** Supine standard care
11. Outcomes
**Primary Outcome:**
- Change in oxygen saturation (SpO₂) post-prone positioning
**Secondary Outcomes:**
- Respiratory rate
- Arterial blood gas values (SaO₂, PO₂, PCO₂, pH, lactate, sodium)
12. Randomization
Simple randomization by drawing lots
Allocation ratio 1:1
13. Blinding
Open-label (no blinding)
14. Statistical Methods
Paired and independent t-tests
Wilk’s Lambda
Cohen’s d for effect size
SPSS used for data analysis
15. Ethical Considerations
Approval: Gazi Yasargil Training and Research Hospital Ethics Committee (15.01.2021 / No:
626)
Verbal and written consent obtained
Conducted per Declaration of Helsinki
16. Data Sharing Plan
Available upon reasonable request from the corresponding author.