Oral Care to Prevent Ventilator-associated Pneumonia

Sponsor

Ataturk University (Other)

Overall Status

Completed

CT.gov ID

NCT05161962

Collaborator

(none)

Enrollment

Location

Arms

5.2

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Hygiene, Oral Health Ventilators, Mechanical	Combination Product: One group received standard oral care. Combination Product: It was applied to the other group by aspiration.	N/A

Detailed Description

The universe of this research, which was designed as a semi-experimental study, is composed of patients connected to the mechanical ventilator lying in Atatürk University Training and Research Hospital Anesthesia and Reanimation Intensive Care Unit between September 2019 and February 2020. A total of 57 patients, 29 method-1, 28 method-2 groups, met the inclusion criteria of the study. In the data collection phase, 'Patient Identifier Information Form', 'Patient Monitoring Form', 'Oral Assessment Scale' and 'Tracheal Aspirate Culture Result Form' were used. In the evaluation of the data, number and percentage distributions, Kruskal Wallis, Mann Withney-U, Wilcoxon Analysis, Chi-Square test were used.

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Investigation of the Effect of Oral Care Given by Two Different Methods in Patients Connected to Mechanical Ventilators on the Development of Ventilator-AssociatedPneumonia

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Jan 23, 2020

Actual Study Completion Date :

Feb 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: One group received standard oral care.	Combination Product: 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. Combination Product: It was applied to the other group by aspiration. the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
Placebo Comparator: It was applied to the other group by aspiration.	Combination Product: 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. Combination Product: It was applied to the other group by aspiration. the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

Arm

Intervention/Treatment

Experimental: One group received standard oral care.

Combination Product: 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.

Combination Product: It was applied to the other group by aspiration.

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

Placebo Comparator: It was applied to the other group by aspiration.

Combination Product: 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.

Combination Product: It was applied to the other group by aspiration.

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

Outcome Measures

Primary Outcome Measures

oral care application with standard oral care stick [1 in 6 hours]
Administered with chlorhexidine gluconate solution.
Oral care application with a sucking oral care stick [1 in 6 hours]
Administered with chlorhexidine gluconate solution.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:• Patients on mechanical ventilator who have been in intensive care for at least 48 hours

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.

Exclusion Criteria: patients with pneumonia Patients younger than 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atatürk University	Erzurum		Turkey

Sponsors and Collaborators

Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ASENA KÖSE, research assistant, Ataturk University

ClinicalTrials.gov Identifier:

NCT05161962

Other Study ID Numbers:

AtaturkU-001

First Posted:

Dec 17, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ASENA KÖSE, research assistant, Ataturk University

Mechanical ventilation

nursing

oral care

pneumonia

Additional relevant MeSH terms:

Pneumonia

Study Results

No Results Posted as of Dec 17, 2021