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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

October 1, 2024

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed

Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 14, 2024

Last Update Submit

November 14, 2024

Conditions

Nosocomial Pneumonia COPD Exacerbation

Keywords

COPDOral careNosocomial pneumoniaChlorhexidine

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Routine oral care (Group 1)

PLACEBO COMPARATOR

Group (1) will receive routine oral care twice daily with gauze for cleansing and tooth brushing

Other: Oral care

Chlorhexidine oral care

ACTIVE COMPARATOR

Group (1) will receive routine oral care twice daily with gauze for cleansing and tooth brushing plus oral care with chlorohexidine solution (concentration 1.2%)

Other: Oral care

Interventions

Oral careOTHER

Oral care done twice daily with chlorhexidine oral care solution (concentration 1.2%)

Chlorhexidine oral careRoutine oral care (Group 1)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Assiut Universitylead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, 711111, Egypt

RECRUITING

Related Publications (2)

Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
PMID: 19952319BACKGROUND
Vilela MC, Ferreira GZ, Santos PS, Rezende NP. Oral care and nosocomial pneumonia: a systematic review. Einstein (Sao Paulo). 2015 Apr-Jun;13(2):290-6. doi: 10.1590/S1679-45082015RW2980. Epub 2015 May 1.
PMID: 25946053BACKGROUND

MeSH Terms

Conditions

Healthcare-Associated PneumoniaPulmonary Disease, Chronic Obstructive

Interventions

Dental Care Team

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic Disease

Intervention Hierarchy (Ancestors)

Patient Care TeamPatient Care ManagementHealth Services Administration

Study Officials

Waleed MD Gamal Elddin Khaleel, Ass. Prof.
Assiut University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Waleed MD Gamal Elddin Khaleel, Ass. Prof.

CONTACT

+201006519722 waleed_gamal@aun.edu.eg

Maiada MD Kamaleldin Hashem, Ass. Prof.

CONTACT

+201006559662 Maiada.hashem@aun.edu.eg

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor of Chest Diseases

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 15, 2024

Study Start

October 1, 2024

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing: Will not share

Locations

EG(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Routine oral care (Group 1)

Chlorhexidine oral care

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations