Clinical trial NCT05760716: The Effect of Prone Position Use Ventilator-Associated Pneumonia in Intensive Care Patients
Official title: The Effect of Prone Position Use on Ventilator Mode, Blood Gas and Ventilator-Associated Pneumonia in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Keywords: prone position
Intensive care
ventilators mechanical
blood gas
ventilator- associated pneumonia
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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'.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient Information Form
timeFrame: 3-5 minutes
measure: Patient Follow-up Charts
timeFrame: 15-20 minutes
Secondary outcomes:
measure: Clinical Pulmonary Infection Score
timeFrame: 3-5 minutes
measure: Braden Pressure Sore Risk Assessment Scale
timeFrame: 5-8 minutes
measure: Ramsey Sedation Scale
timeFrame: 5-8 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
References: