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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05760716
Other study ID # f8c2xi67
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date November 1, 2022

Study information

Verified date March 2023
Source Istanbul Arel University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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'.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Intervention

Other:
practicing prone position
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.

Locations

Country Name City State
Turkey Istanbul University Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Arel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Information Form demographics 3-5 minutes
Primary Patient Follow-up Charts On vital signs 15-20 minutes
Secondary 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. 3-5 minutes
Secondary 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. 5-8 minutes
Secondary 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 5-8 minutes
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