NCT05161962

Brief Summary

This study was conducted to investigate the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

December 5, 2021

Last Update Submit

December 5, 2021

Conditions

Keywords

Mechanical ventilationnursingoral carepneumonia

Outcome Measures

Primary Outcomes (2)

  • oral care application with standard oral care stick

    Administered with chlorhexidine gluconate solution.

    1 in 6 hours

  • Oral care application with a sucking oral care stick

    Administered with chlorhexidine gluconate solution.

    1 in 6 hours

Study Arms (2)

One group received standard oral care.

EXPERIMENTAL
Combination Product: One group received standard oral care.Combination Product: It was applied to the other group by aspiration.

It was applied to the other group by aspiration.

PLACEBO COMPARATOR
Combination Product: One group received standard oral care.Combination Product: It was applied to the other group by aspiration.

Interventions

the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

It was applied to the other group by aspiration.One group received standard oral care.

the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

It was applied to the other group by aspiration.One group received standard oral care.

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients over the age of 18
  • Patients without thrombocytopenia, leukopenia and oral stomatitis, aphthae, candiasis, gingivitis
  • Patients whose respiratory support is provided by a mechanical ventilator
  • Patients who are considered to be able to provide mechanical ventilator support for 7 days
  • Patients without any respiratory-related infectious pathogens
  • Obtaining informed consent from the patient if he/she can give consent or from his/her guardian if he/she is unable to give consent.
  • It was determined as patients who did not undergo any intraoral surgical intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

December 5, 2021

First Posted

December 17, 2021

Study Start

September 1, 2019

Primary Completion

January 23, 2020

Study Completion

February 5, 2020

Last Updated

December 17, 2021

Record last verified: 2021-12

Locations