NCT06997666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 26, 2025

Last Update Submit

May 28, 2025

Conditions

Keywords

ARDSCOVID-19NursingBlood gas valuesProne position

Outcome Measures

Primary Outcomes (1)

  • Change in Oxygen Saturation (SpO₂)

    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.

    Baseline and six repeated measurements over two consecutive days

Secondary Outcomes (1)

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

    Baseline and six repeated measurements over two consecutive days

Other Outcomes (2)

  • Change in Respiratory Rate

    Baseline and six repeated measurements over two consecutive days

  • Change in Serum Lactate and Sodium Levels

    Baseline and six repeated measurements over two consecutive days

Study Arms (2)

Prone Position Group

EXPERIMENTAL

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.

Procedure: Prone Position

Supine Standard Care Group

NO INTERVENTION

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.

Interventions

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.

Prone Position Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diyarbakır Provincial Health Directorate, 21000, Diyarbakır, Turkey

Diyarbakır, 21500, Turkey (Türkiye)

Location

Related Publications (1)

  • Tekin V, Korkmaz M. The effect of prone position on oxygen saturation, blood gas parameters, and respiratory rate in intensive care patients with COVID-19-induced ARDS. Sci Rep. 2025 Nov 29;16(1):108. doi: 10.1038/s41598-025-28844-3.

MeSH Terms

Conditions

COVID-19Acute Lung Injury

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLung Injury

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 26, 2025

First Posted

May 30, 2025

Study Start

March 1, 2021

Primary Completion

August 30, 2021

Study Completion

November 30, 2021

Last Updated

May 30, 2025

Record last verified: 2025-05

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