prone: The Effect of Prone Position Use Ventilator-Associated Pneumonia in Intensive Care Patients

Sponsor
Istanbul Arel University (Other)
Overall Status
Completed
CT.gov ID
NCT05760716
Collaborator
(none)
80
1
17
4.7

Study Details

Study Description

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'.

Condition or Disease Intervention/Treatment Phase
  • Other: practicing prone position

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

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Prone Position Use on Ventilator Mode, Blood Gas and Ventilator-Associated Pneumonia in Intensive Care Patients
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Jul 1, 2022
Actual Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Patient Information Form [3-5 minutes]

    demographics

  2. Patient Follow-up Charts [15-20 minutes]

    On vital signs

Secondary Outcome Measures

  1. Clinical Pulmonary Infection Score [3-5 minutes]

    '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.

  2. Braden Pressure Sore Risk Assessment Scale [5-8 minutes]

    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.

  3. Ramsey Sedation Scale [5-8 minutes]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University Cerrahpasa Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Arel University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Burcu DEDEOĞLU DEMİR, Assistant Professor, Istanbul Arel University
ClinicalTrials.gov Identifier:
NCT05760716
Other Study ID Numbers:
  • f8c2xi67
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Burcu DEDEOĞLU DEMİR, Assistant Professor, Istanbul Arel University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023