The Effect of Two Different Oral Care Solutions on the Prevention of Ventilator-associated Pneumonia in the Intensive Care Unit

NCT06733090 | Active Not Recruiting

• 1 other identifier: 0382
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilator-associated pneumonia (VAP) is a lung parenchymal tissue infection that develops nosocomially 48-72 hours after the start of mechanical ventilation (8, 15, 17, 23, 31). The second most common nosocomial infection in intensive care units in the United States is VAP (20). Approximately 90% of pneumonias developing in intensive care units are seen in patients receiving mechanical ventilation support, while the risk of VAP development is higher in the first days of hospitalization, and has been reported to be 3%/day in the first 5 days, 2%/day on the following six and ten days, and 1%/day on subsequent days (7, 20, 23,37). The concept of the Bundle of Care was first defined by the Institute for Healthcare Improvement in 2005 (21, 25). The Bundle of Care; It is a set of practices that have been beneficial in terms of clinical improvement, each of which includes 3-5 evidence-based, preventive interventions that contribute to the quality of care (5, 21, 25, 26, 30). There are studies in the literature showing that the use of the Care Bundle for the development of VAP reduces the rate of VAP development (5, 30, 34, 29, 28). Evidence-based practices frequently recommended in the literature within the scope of the VAP Care Bundle are; giving the patient a semi-fowler position (sitting at a 30-45 degree angle), evaluating daily extubation, evaluating daily sedation, peptic ulcer prophylaxis unless contraindicated, and deep vein thrombosis prophylaxis (15, 21, 23, 26, 28, 30). Health Care Improvement Institute; recommends washing hands before and after patient contact, removing subglottic secretions, and not changing ventilator circuits earlier than 48 hours (19, 21, 32, 33). In addition to evidence-based practices, the Institute for Health Care Improvement recommends that oral intubation be preferred to nasotracheal intubation, endotracheal tube cuff pressure should be between 20-30 cmH2O, enteral feeding should be initiated within 24-48 hours for hemodynamically stable intensive care patients, oral care should be performed with an antiseptic solution at 2-12 hour intervals, including teeth, cheeks, and tongue, monitoring humidifier filters and irrigation solutions, and aspiration should be performed under appropriate conditions. These interventions are considered evidence-based (1, 2, 3, 8, 9, 10, 11, 12, 14, 16, 18, 22, 23, 26, 33). The evidence-based Care Bundle Interventions to be implemented by the researcher within the scope of this study are listed below. Interventions to be implemented by the nurse's decision include; Oral care with 0.12% chlorhexidine glucanate or 0.2% chlorhexidine glucanate solution, 4 times a day, at 6-hour intervals, semi-fowler position (sitting at a 30-45 degree angle) unless contraindicated, monitoring the endotracheal tube cuff pressure to be between 20-30 cmH2O, changing ventilator circuits and humidifier filters in case of visible contamination or malfunction, and monitoring the aspiration application. Interventions to be implemented by the physician's decision include; includes daily extubation assessment, peptic ulcer prophylaxis unless contraindicated, deep vein thrombosis prophylaxis unless contraindicated.

Conditions

Intensive Care Patients; Oral Care Performance; Intensive Care Nurses

Keywords

intensive care; oral care; oral care performance

Outcome Measures

Primary Outcomes (5)

• APACHE II (Acute Physiology and Chronic Health Evalution II

  Patients will be examined immediately after 24 hours after being admitted to intensive care. It will be looked at once.

  It is filled only once for each patient, at the end of the 24th hour.

• Follow-up period of patients checklist

  It indicates how long patients will be followed. Patients are followed until they are discharged from intensive care and until they die. If ex or not discharged, the longest period is determined as 30 days.

  If ex or not discharged, the longest period is determined as 30 days.

• CPIS Clinical Pulmonary Infection Score

  CPIS (Clinical Pulmonary Infection Score) will be filled in on the 1st, 3rd and 5th hospital days.

  It is filled out once for the 1st, 3rd and 5th days when the patient is admitted to the intensive care unit.

• GKS Glasgow Coma Scale

  GKS Glasgow Coma Scale, It will be checked once a day every day. It is a method that aims to record a person's state of consciousness reliably and objectively at the beginning and in subsequent evaluations. When the patient is evaluated according to the criteria of the scale, the patient is given scores between 3 (indicating profound loss of consciousness) and 14 (according to the original scale) or 15 (according to the widely used corrected scale).

  once a day on the day the patient is admitted to the intensive care unit, for a maximum of 30 days until death or discharge, whichever came first

• Oral Health Evaluation Form

  The oral health of the patients will be checked once a day by the researcher from the first moment throughout the study.

  once a day on the day the patient is admitted to the intensive care unit, for a maximum of 30 days until death or discharge, whichever came first

Study Arms (2)

0.2% chlorhexidine glucanate solution

EXPERIMENTAL

0.2% chlorhexidine glucanate solution

Drug: 0.2% chlorhexidine glucanate solution

0.12% chlorhexidine glucanate solution

EXPERIMENTAL

0.12% chlorhexidine glucanate solution

Drug: 0.12% chlorhexidine glucanate solution

Interventions

0.12% chlorhexidine glucanate solution DRUG

The superiority of two different solutions over each other will be examined with a standard maintenance.

0.12% chlorhexidine glucanate solution

0.2% chlorhexidine glucanate solution DRUG

0.2% chlorhexidine glucanate solution

0.2% chlorhexidine glucanate solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive mechanical ventilation support (at least 48 hours) 18 years of age or older Obtaining the approval of the legal guardian for his/her care

You may not qualify if:

• Chronically dependent on a ventilator Chlorhexidine gluconate sensitivity Diagnosed with VAP before the data collection process Semi-fawler position not applicable

Sponsors & Collaborators

• MELEK UNLUGEDIK: lead

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Avcilar, 34320, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Istanbul University - Cerrahpasa (IUC)

Model Details: The study will be conducted in two stages. In the first stage; Nurse Information Form and Ventilator Associated Pneumonia Knowledge pretest will be applied to nurses who accept to participate in the study before the training. A 2-week training program will be applied to nurses by the researcher. In the second stage of the study, the forms in the second stage will be applied to patients who meet the criteria for inclusion in the study and the process will be followed in the same way in two separate groups. According to the research sample calculation, it is planned to include at least 25 patients in the experimental group and 25 patients in the control group.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 13, 2024
• Study Start: October 23, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)