Intensive Care Unit SyndromeproneNCT05760716
The Effect of Prone Position Use Ventilator-Associated Pneumonia in Intensive Care Patients
An observational study of Intensive Care Unit Syndrome, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- practicing prone position
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prone Position Use on Ventilator Mode, Blood Gas and Ventilator-Associated Pneumonia in Intensive Care Patients
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'.
Read the detailed description
Patients hospitalized in intensive care units are intubated and taken to mechanical ventilation support due to reasons such as inability to maintain airway patency, increase in respiratory/myocardial workload, and insufficient gas exchange. One of the strategies used to increase the effectiveness of mechanical ventilation therapy is the prone position (PP) application. In order to increase lung capacity and improve oxygenation in acute lung failure, the prone position was first applied in mechanical ventilation in the 1970s. Studies have shown that the prone position is protective against preventing ventilator-induced lung damage, and it has been found to increase PaO2/FiO2 in 70% of intensive care patients with severe hypoxemia receiving MV support. The reduction of the pressure on the lungs and the more homogeneous lung perfusion are effective in protecting the lungs in patients with prone position. Prone positioning of intensive care patients; It includes the risk of serious complications such as endotracheal tube obstruction, unplanned extubations, tachy and bradyarrhythmias, loss of venous and arterial access, cardiac arrest and pressure ulcer development in anterior body surface areas.
Positioning is one of the practices that nurses use by using their professional knowledge and skills. The positive effects of the position given to the patients in the intensive care unit on treatment and care are stated. Nurses continue to play a key role in the follow-up and treatment of patients who are placed in the prone position under mechanical ventilation therapy, from the continuous evaluation of the patients to the implementation of care practices, to provide the best clinical results.
In this study, a randomized controlled experiment was planned to determine the effect of the prone position by evaluating the mechanical ventilator values, blood gas and ventilator-associated pneumonia status before the position is applied, during the position and after the patients are brought back to the supine position by comparing the groups with and without the prone position.
The aims of the research;
- How prone position affects ventilator mode values
- How the prone position affects blood gas results,
- To examine how prone position affects the rate of development of ventilator-associated pneumonia.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- practicing prone position
- Keywords
- prone position, Intensive care, ventilators mechanical, blood gas, ventilator- associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
practicing prone positionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
demographics
Measured: 3-5 minutes
Patient Follow-up Charts
On vital signs
Measured: 15-20 minutes
Secondary outcomes (3)
Clinical Pulmonary Infection Score
'Clinical Pulmonary Infection Score' (CPES); It examines seven clinical parameters including leukocyte count, body temperature, endotracheal aspirate (ETA)/microbiological culture results, amount and character of tracheal secretion, Pa02/Fi02 ratio, and presence of pulmonary infiltration. A score of 6 or more suggests VIP.
Measured: 3-5 minutes
Braden Pressure Sore Risk Assessment Scale
The 'Braden Pressure Sore Risk Assessment Scale' (BBIRRS) consists of '6 sub-dimensions' and '19 risk assessments'. 'Perception of stimulus, activity, movement, humidity, nutrition items are between 1-4 points; friction-tear is evaluated between 1-3 points. As the scores obtained from the scale decrease, the risk of developing pressure ulcers increases, individuals with a scale score of '3-14' are considered to be at 'moderate' risk for the development of pressure sores, and those with a score of '15-16' are considered to be 'low risk'. The total score of the scale varies between '6-23' points.
Measured: 5-8 minutes
Ramsey Sedation Scale
The scale includes 1 to 6 points. 1 point: alert, anxious and/or restless, 2 points: alert, cooperative, oriented, calm, 3 points: sleeping, responding to verbal stimulus, 4 points: sleeping, moderately responding to painful stimulus , 5 points: sleeping, responding slowly to painful stimulus, 6 points: sleeping, no response to painful stimulus. The lowest score on the scale: 1: agitation, the highest score 6: deep sedation
Measured: 5-8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Jun 2021
- Primary completion1 Jul 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu DEDEOĞLU DEMİR, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760716
- Sponsor's protocol ID
- f8c2xi67
- Acronym
- prone
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39984994
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prone Position Use on Ventilator Mode, Blood Gas and Ventilator-Associated Pneumonia in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05760716
- Acronym / sponsor ID
- prone / f8c2xi67
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- prone position, Intensive care, ventilators mechanical, blood gas, ventilator- associated pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Detailed description
Patients hospitalized in intensive care units are intubated and taken to mechanical ventilation support due to reasons such as inability to maintain airway patency, increase in respiratory/myocardial workload, and insufficient gas exchange. One of the strategies used to increase the effectiveness of mechanical ventilation therapy is the prone position (PP) application. In order to increase lung capacity and improve oxygenation in acute lung failure, the prone position was first applied in mechanical ventilation in the 1970s. Studies have shown that the prone position is protective against preventing ventilator-induced lung damage, and it has been found to increase PaO2/FiO2 in 70% of intensive care patients with severe hypoxemia receiving MV support. The reduction of the pressure on the lungs and the more homogeneous lung perfusion are effective in protecting the lungs in patients with prone position. Prone positioning of intensive care patients; It includes the risk of serious complications such as endotracheal tube obstruction, unplanned extubations, tachy and bradyarrhythmias, loss of venous and arterial access, cardiac arrest and pressure ulcer development in anterior body surface areas.
Positioning is one of the practices that nurses use by using their professional knowledge and skills. The positive effects of the position given to the patients in the intensive care unit on treatment and care are stated. Nurses continue to play a key role in the follow-up and treatment of patients who are placed in the prone position under mechanical ventilation therapy, from the continuous evaluation of the patients to the implementation of care practices, to provide the best clinical results.
In this study, a randomized controlled experiment was planned to determine the effect of the prone position by evaluating the mechanical ventilator values, blood gas and ventilator-associated pneumonia status before the position is applied, during the position and after the patients are brought back to the supine position by comparing the groups with and without the prone position.
The aims of the research;
- How prone position affects ventilator mode values
- How the prone position affects blood gas results,
- To examine how prone position affects the rate of development of ventilator-associated pneumonia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment Group | – | Other: practicing prone position* 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| practicing prone positionWash 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. | Other | Experiment Group |
Primary outcome
Patient Information Form
Time frame: 3-5 minutes
demographics
Patient Follow-up Charts
Time frame: 15-20 minutes
On vital signs
3 secondary outcomes
Clinical Pulmonary Infection Score
Time frame: 3-5 minutes
Braden Pressure Sore Risk Assessment Scale
Time frame: 5-8 minutes
Ramsey Sedation Scale
Time frame: 5-8 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 39984994Dedeoglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: 3-5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05760716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.