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Clinical Trials/NCT06691399
NCT06691399
Recruiting
Not Applicable

Routine Oral Care Versus Chlorhexidine Oral Care on Incidence of Nosocomial Pneumonia and Oral Health Among Critically Ill Non-intubated Patients With COPD

Assiut University1 site in 1 country60 target enrollmentStarted: October 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Incidence of nosocomial pneumonia

Overview

Brief Summary

Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia.

Detailed Description

Infection is a common problem and a major cause of morbidity and mortality for patients in intensive care units (ICUs). Pneumonia is the most common site of infection according to an international study of the prevalence and outcomes of infection in ICUs, which included 13,796 patients. Nosocomial pneumonia (NP) is among the leading causes of mortality in patients in the ICU. Notably, the incidence of nosocomial pneumonia is increasing, and the number of infection-related deaths that follow is also increasing. Thus, preventing nosocomial pneumonia is a cost reducing and life-saving health care practice, especial in ICUs.

Nosocomial pneumonia (NP) was defined as an infection of the lower respiratory tract that does not exist at the time of admission and does not have an incubation period of infection but occurs 48 hours after admission. The most important cause for the development of nosocomial pneumonia is the oral environment. The oral cavity of ICU patients is an important reservoir for bacteria and provides a habitat for microorganisms that can lead to nosocomial pneumonia. Patients in ICUs acquire pneumonia by aspirating oral bacteria that have been colonized in the oral cavity into the lower respiratory tract. Due to advanced age, limited mobility, illness, and cognitive dysfunction, patients in ICUs often have difficulty maintaining oral hygiene by themselves.

Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia. The aim of the present study is to assess value of preventive strategy using chlorhexidine for oral care among non-intubated COPD patients admitted to ICU upon incidence of nosocomial pneumonia.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients diagnosed as COPD
  • admitted to ICU with acute exacerbation
  • need for noninvasive ventilatory support including noninvasive ventilation anf high flow nasal cannula

Exclusion Criteria

  • patients refusing to participate
  • End stage organ failure (Heart Failure, Liver cell failure and/or Renal failure

Outcomes

Primary Outcomes

Incidence of nosocomial pneumonia

Time Frame: 1 month

Incidence of nosocomial pneumonia diagnosed via clinical features and confirmed with either chest ultrasonography or chest radiography

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Waleed Gamal Elddin Khaleel

Assistant Professor of Chest Diseases

Assiut University

Study Sites (1)

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