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NCT Number: NCT06997666

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

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.

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Key information

Conditions

COVID - 19 ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Lung Injury Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diyarbakır Provincial Health Directorate, 21000, Diyarbakır, Turkey

Diyarbakır, 21500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prone position

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.

Primary outcomes

  1. Change in Oxygen Saturation (SpO₂)

    Time frame: Baseline and six repeated measurements over two consecutive days

    Measurement of arterial oxygen saturation (SaO₂), partial pressure of oxygen (PO₂), partial pressure of carbon dioxide (PCO₂), and pH from blood gas analysis to assess respiratory and metabolic effects of prone positioning.

Secondary outcomes

  1. Change in Arterial Blood Gas Parameters (SaO₂, PO₂, PCO₂, pH)

    Time frame: Baseline and six repeated measurements over two consecutive days

    Measurement of arterial oxygen saturation (SaO₂), partial pressure of oxygen (PO₂), partial pressure of carbon dioxide (PCO₂), and pH from blood gas analysis to assess respiratory and metabolic effects of prone positioning.

Other outcomes

  1. Change in Respiratory Rate

    Time frame: Baseline and six repeated measurements over two consecutive days

    Monitoring of respiratory rate (breaths per minute) before and after prone positioning to assess its impact on breathing efficiency.

  2. Change in Serum Lactate and Sodium Levels

    Time frame: Baseline and six repeated measurements over two consecutive days

    Assessment of serum lactate and sodium concentrations to identify any metabolic changes associated with prone positioning.

Sponsors and collaborators

Lead sponsor

Medet Korkmaz

Other

Registry information

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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