Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-26 @ 6:45 PM
Study NCT ID:
NCT06997666
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2025-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prone Position on Oxygen, Blood Gas, and Respiratory Parameters in Intensive Care Patients With COVID-19-induced ARDS
Sponsor:
Medet Korkmaz
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: