Implementing Oral Care Bundle on Critical Care Nurses' Practice and Mechanically Ventilated Patients' Outcomes

NCT05351619 | Unknown DMC

• 1 other identifier: 0222
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Oral care is a fundamental aspect of nursing that impact the health and comfort of patients over both the short and long term. Caring for very sick patients in a busy stressful environment may result in oral care having a lower priority for nurses than other aspects of care (Sarangi, Simon, \& Sarangi, 2021). Negligence of these interventions can cause long-term oral problems and nosocomial diseases most notably VAP (Abd Alraheem, 2020). A study conducted by Ayşe et al. (2019) reported that the application of regular oral care for the MV patients as a part of care protocols decreased bacterial colonization and had a protective and improving effect on oral health. A recent study conducted by Rizk, Saad-eldeen and Helmy (2020) concluded that VAP is a serious ICU acquired infection with significant impact and required effective preventive action. A systematic review conducted by Kharel, Bist and Mishra (2021) concluded that VAP is a critical issue in ICU with a high-cost burden and various interventional educational programs like staff training and hygiene awareness can reduce the future risk of VAP. A recent study conducted by Abd Alraheem (2020) illustrated that 53.3% of the MV patients had average oral alteration. Asystematic review conducted by Kharel et al. (2021) to assess VAP among ICU patients in WHO South east Asian region illustrated that the VAP incidence rate ranged from 0.2% to 11.6% differing greatly between countries. The highest VAP prevalence rate was reported from the medical ICU, India, where as the lowest was from the palliative care ICU, South Korea. In Egypt, analysis of VAP was done in some Egyptian University Hospitals by Fathy, Abdelhafeez, EL-Gilany and Abd Elhafez, (2013) who reported that the incidence of VAP ranged from 16% to 75%, the lowest ratio was in Alexandria University 16% and the highest one in Ain Shams University 75%. The incidence in Mansoura University Hospitals (MUH) was 22.6%. Another recent study conducted by Elkolaly, Bahr, El-Shafey, Basuoni, and Elber (2019) reported that the incidence of VAP in Tanta University Hospitals is still high (38.4%). Many studies investigated the effect of oral care with chlorhexidine on the incidence of VAP and oral health in MV patients (Abd Alraheem, 2020; Collins et al., 2020; Heck, 2012; Moustafa, Tantawey, El-Soussi and Ramadan, 2016; Plantinga et al., 2016). However, the recent reappraisal of the evidence suggests that chlorhexidine does not reduce VAP, causes excess mortality in non-cardiac surgery patients (Dale et al., 2019) and unexpected high incidence of oral mucosal lesions (Plantinga et al., 2016). Moreover, from my empirical experience, chlorhexidine is not available in all Egyptian hospitals because of its economic burden. A study conducted by Moustafa et al. (2016) recommended regular updates about evidence-based guidelines for oral care and its effect on VAP prevention and oral health. The debate of the literature about oral care inspired us to investigate this area.

Conditions

Ventilator Associated Pneumonia

Keywords

oral care bundle, Critical Care Nurses' Practice, Mechanically Ventilated Patients

Outcome Measures

Primary Outcomes (1)

• oral health

  The oral assessment scale will be used to assess the oral health. It is composed of 6 items including the lips, tongue, saliva, mucous membrane, gums, and teeth.

  one week

Secondary Outcomes (1)

• Ventilator associated pneumonia

  one week

Study Arms (2)

An intervention group

EXPERIMENTAL

An intervention group: will include 41 patients who will receive the oral care bundle.

Procedure: oral care bundle implementation

A control group

NO INTERVENTION

A control group: will include 41 patients who will receive the traditional oral care.

Interventions

oral care bundle implementation PROCEDURE

oral care bundle encompasses oral assessment, tooth brushing, oral / lip moisturization, and suctioning oropharyngeal secretions above the cuff.

An intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient \> 18 years old.
• Orally intubated mechanically ventilated patients for at least 48 hours.

You may not qualify if:

• Patients will be excluded from the study if they have:
• A clinical diagnosis of pneumonia at the time of admission and/or a modified Clinical Pulmonary Infection Score of 6 or greater.
• Contraindication to oral care intervention such as severe oral trauma, oral ulcerations, facial fractures, or unstable cervical fractures.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Emergency Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nagwa Yehya, Ph D

CONTACT

01094712623; nagwayehya@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be conducted in three phases; preparation, implementation, and evaluation. Implementation phase * For nurses: * Nurses' demographic characteristics will be collected by using part I of tool I. * Critical care nurses' practice of the oral care bundle will be observed by using part II of tool I. * For patients: * An initial assessment will be carried out for all MV patients in selected ICUs on admission to confirm that they are free from exclusion criteria. * Patients' characteristics and health-relevant data will be collected by the PI on the first day of admission using part I of tool II. * Assessment of the occurrence of VAP will be done for both groups on the first, third, and sixth days of the patient's admission to the ICU by using part II of tool II. * An oral assessment scale will be carried out for both groups on the first, third, and sixth days of patient admission by using part III of tool II.

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: February 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

EG (1)