Effect of Prone Position on Oxygen, Blood Gas, and Respiratory Parameters in Intensive Care Patients With COVID-19-induced ARDS

NCT ID: NCT06997666

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-11-30

Brief Summary

This randomized controlled trial aimed to investigate the effect of the prone position on oxygen saturation, arterial blood gas parameters, and respiratory rate in intensive care patients diagnosed with COVID-19-induced Acute Respiratory Distress Syndrome (ARDS). A total of 90 patients (45 in the prone positioning group and 45 in the control group) were included. The intervention group received a 30-minute prone positioning procedure, while the control group received standard ICU care. Data were collected using a Demographic Information Form and clinical monitoring of respiratory and blood gas parameters across six time points over two days.

Detailed Description

This randomized controlled trial investigated the short-term physiological effects of prone positioning in intubated intensive care patients diagnosed with COVID-19-induced Acute Respiratory Distress Syndrome (ARDS). A total of 90 patients were included, with 45 in the experimental group and 45 in the control group. Patients in the experimental group were placed in the prone position for 30 minutes on two consecutive days, while the control group received standard ICU care without prone positioning.

Oxygen saturation (SpO₂, SaO₂), arterial blood gas parameters (PO₂, PCO₂, pH, lactate, sodium), and respiratory rate were measured at six time points to evaluate the effectiveness of the intervention. The study was conducted in the general and intermediate intensive care units of a public hospital in eastern Turkey, which was designated as a COVID-19 treatment center during the pandemic.

The study's primary objective was to determine whether prone positioning could improve oxygenation and respiratory efficiency in critically ill patients with COVID-19-related ARDS. Secondary outcomes included changes in blood gas and metabolic parameters. The results suggested that prone positioning had a beneficial impact on oxygen saturation and respiratory rate without causing adverse changes in blood gas chemistry. The study was ethically approved and conducted in accordance with the Declaration of Helsinki.

Conditions

COVID - 19; ARDS (Acute Respiratory Distress Syndrome)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Prone Position Group

Patients in this group were placed in the prone position for 30 minutes once daily on two consecutive days. Oxygen saturation (SpO₂), blood gas parameters (SaO₂, PO₂, PCO₂, pH, lactate, sodium), and respiratory rate were measured before and after the intervention. No other treatment was altered.

Group Type: EXPERIMENTAL

Prone Position

Intervention Type: PROCEDURE

Patients assigned to the Prone Position Group were placed in the prone position (lying face down) for 30 minutes once daily over two consecutive days while hospitalized in the ICU for COVID-19-induced ARDS. The intervention was performed between 12:30 and 13:00 under nurse supervision. Oxygen saturation, blood gas parameters (SaO₂, PO₂, PCO₂, pH, lactate, sodium), and respiratory rate were measured before and after each prone positioning session. The procedure was standardized across patients and no additional treatments were introduced during the intervention period.

Supine Standard Care Group

Patients in this group received standard intensive care in the supine position. No additional interventions were applied. Oxygen saturation (SpO₂), blood gas parameters (SaO₂, PO₂, PCO₂, pH, lactate, sodium), and respiratory rate were measured at the same intervals as the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prone Position

Patients assigned to the Prone Position Group were placed in the prone position (lying face down) for 30 minutes once daily over two consecutive days while hospitalized in the ICU for COVID-19-induced ARDS. The intervention was performed between 12:30 and 13:00 under nurse supervision. Oxygen saturation, blood gas parameters (SaO₂, PO₂, PCO₂, pH, lactate, sodium), and respiratory rate were measured before and after each prone positioning session. The procedure was standardized across patients and no additional treatments were introduced during the intervention period.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 40 years or older
• Admission to an intensive care unit (ICU)
• Confirmed diagnosis of COVID-19
• Developed Acute Respiratory Distress Syndrome (ARDS) due to COVID-19
• Intubated at the time of enrollment
• Provided informed verbal and written consent (or consent provided by legal representative)

Exclusion Criteria

• Significant hearing or vision impairments affecting communication
• Cognitive impairment or inability to understand instructions
• Patient died during the course of the study
• Early discharge from intensive care before completion of all measurements
• Non-intubated patients whose level of consciousness could not be monitored

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medet Korkmaz

OTHER

Sponsor Role: lead

Responsible Party

Medet Korkmaz

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Diyarbakır Provincial Health Directorate, 21000, Diyarbakır, Turkey

Diyarbakır, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

626

Identifier Type: -

Identifier Source: org_study_id