NCT05760716

Brief Summary

The aim of this experimental study was to investigate the effect of prone position use on ventilator values, blood gas and ventilator-associated pneumonia in intensive care unit patients. Between June 2021 and January 2022, 40 trials and 40 control patients were included in the intensive care units of two private hospitals and received mechanical ventilation support. The mechanical ventilator values, arterial blood gases and ventilator-related pneumonia conditions were evaluated and followed for at least 5 to 10 days just before the position was given by comparing the prone position (PP) and the patients were brought back into the supine position. The data were collected using 'Patient Follow-up Charts', 'Clinical Pulmonary Infection Score', 'Braden Pressure Half Risk Assessment' and 'Ramsey Sedation Scale' prepared in line with patient introduction form and evidence-based guidelines. In addition, life findings, cultural results and blood gas analyses were performed. Statistical analysis was performed using the 'NCSS (Number Cruncher Statistical System) 2007 (Kaysville, Utah, USA)' program. 'Descriptive statistics, parametric and nonparametric tests' were used to evaluate the data. The level of statistical signiation was considered 'p\<0.05'.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

June 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 10, 2023

Last Update Submit

March 6, 2023

Conditions

Keywords

prone positionIntensive careventilators mechanicalblood gasventilator- associated pneumonia

Outcome Measures

Primary Outcomes (2)

  • Patient Information Form

    demographics

    3-5 minutes

  • Patient Follow-up Charts

    On vital signs

    15-20 minutes

Secondary Outcomes (3)

  • Clinical Pulmonary Infection Score

    3-5 minutes

  • Braden Pressure Sore Risk Assessment Scale

    5-8 minutes

  • Ramsey Sedation Scale

    5-8 minutes

Study Arms (2)

Experiment Group

* The prone position was positioned within the application steps. * The introductory characteristics form of the patients was filled in on the day the patient was included in the study. * Blood gas results and mechanical ventilator respiration indicators were followed up in the PP for 5-10 days and the changes were recorded in the tolerance hours. Arterial blood gas results, mechanical ventilator values, and ventilator-associated pneumonia status were monitored before the position was applied, during the position and after the patients were placed in the supine position by comparing the groups with and without the prone position. • Nursing intervention application steps for VAP were followed during the PP and the changes were recorded.

Other: practicing prone position

Control Group

Routine nursing care was applied without any intervention. 'Patient Information Form', 'Patient Follow-up Charts', 'Clinical Pulmonary Infection Score', 'Braden Pressure Wound Risk Assessment' and 'Ramsey Sedation Scale' were used.

Interventions

Wash your hands. Prepare the materials. Before starting the procedure, inform the patient and explain the procedure. Ensure patient privacy. Raise the guardrail opposite the work area. Take the proper posture. Pay attention to body mechanics. Lay the patient on their back in the middle of the bed. Place a pillow under the patient's head to cover their shoulders. Extend arms to side of body with elbows slightly bent inward (flexion). Place a pillow under your arms. Place roller in palm. Place a thin pillow or a thinly folded towel/sheet under the waist. Place a thin towel under the knees. Support the bottom of the ankles with a pillow. Support the soles of the feet with a foot board. Raise the guardrail on the working side. Inform the patient that they can stay in this position for a maximum of 2 hours.

Experiment Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The research was carried out between June and December 2021 in the 14-bed and 26-bed general intensive care units of two private hospitals on the European side of Istanbul. Power analysis was performed with the 'G\*Power (v3.1.7) program' in the sample calculation. In general, studies should have 80% power. The power of the study is expressed as '1-β (β = II type error probability)'. Evaluations to be made with two independent groups; Since it is assumed to have a large effect size (d=0.8), according to the calculation made, it was determined that there should be at least 26 people in the groups at the level of 'α=0.05' according to Cohen's effect size coefficients. Considering that there may be losses during the study process, 40 people were included in each group.

You may qualify if:

  • Being 18 years or older,
  • Receiving respiratory support with a mechanical ventilator in the ICU,
  • COVID 19 test negative,
  • Consent by the first degree relative.

You may not qualify if:

  • Being under the age of 18,
  • Receiving a diagnosis of VAP before admission to the ICU,
  • Having a positive COVID 19 test,
  • Presence of an obstacle to prone positioning (obesity, pregnancy, anterior chest wall surgery, advanced heart failure, etc.).
  • Not giving consent to participate in the study by a first-degree relative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Dedeoglu Demir B, Enc N, Borekci S. The effect of prone positioning on ventilator parameters, blood gas levels, and ventilator-associated pneumonia in intensive care unit patients: a randomized controlled trial. BMC Nurs. 2025 Feb 21;24(1):203. doi: 10.1186/s12912-025-02817-3.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 10, 2023

First Posted

March 8, 2023

Study Start

June 1, 2021

Primary Completion

July 1, 2022

Study Completion

November 1, 2022

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations