Clinical trial NCT06997666: Effect of Prone Position on Oxygen, Blood Gas, and Respiratory Parameters in Intensive Care Patients With COVID-19-induced ARDS
Official title: The Effect of Prone Position on Oxygen Saturation, Blood Gas Parameters, and Respiratory Rate in Intensive Care Patients With COVID-19-induced ARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID - 19
ARDS (Acute Respiratory Distress Syndrome)
Keywords: ARDS
COVID-19
Nursing
Blood gas values
Prone position
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Oxygen Saturation (SpO₂)
timeFrame: Baseline and six repeated measurements over two consecutive days
Secondary outcomes:
measure: Change in Arterial Blood Gas Parameters (SaO₂, PO₂, PCO₂, pH)
timeFrame: Baseline and six repeated measurements over two consecutive days
Other outcomes:
measure: Change in Respiratory Rate
timeFrame: Baseline and six repeated measurements over two consecutive days
measure: Change in Serum Lactate and Sodium Levels
timeFrame: Baseline and six repeated measurements over two consecutive days
Locations:
city: Diyarbakır
country: Turkey
facility: Diyarbakır Provincial Health Directorate, 21000, Diyarbakır, Turkey
Study officials:
References: