Oral Care of Intubated Intensive Care Patient

NCT ID: NCT06258603

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-06-19

Brief Summary

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The aim of the research was to examine the effect of oral care bundle application on oral health, salivary pH (power of hydrogen), dry mouth and ventilator associated pneumonia in intubated patients compared to standard oral care.

Detailed Description

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Maintaining the integrity of the oral mucosa in intensive care unit patients is very important due to its close relationship with systemic health, disease risk and self-image, as well as comfort and nutrition. Serious problems develop in patients who have no or insufficient saliva movement or production, are unconscious, or have an artificial airway. Oral health problems, which begin with the deterioration of the saliva flow and content of intubated patients, lead to much more risky and costly situations that end in ventilator associated pneumonia. In the literature, it is seen that oral care practices performed in accordance with protocols increase the risk of complications and that bundle care practices used in different care areas increase the performance of care.In this randomized controlled study, people who were aged between 18 and 70, had received mechanical ventilation support, were intubated orally and in the first 24 hours of intubation, and had a stable hemodynamic status were included in the study.

Conditions

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Pneumonia Mechanical Ventilation Complication Salivation Dry Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomization of the study was achieved by the faculty member of the University's Faculty of Medicine, Department of Biostatistics and Medical Informatics, with the R version 3.1.3 program. First of all, the individuals included in the study were stratified according to two age groups (19-44 years and 45-70 years) in the computer environment. Then, individuals in each age group were included in the experimental and control groups in a balanced manner using the block randomization method. The randomization list was hidden from the researcher and the patient and was given to the researcher by a third party during the application. Eligibility and randomization assessment was performed by a critical care nurse independent of the study.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single Blinded

Study Groups

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Patients who received oral care bundle

"A oral care bundle" protocol created by the researchers and it was applied by a researcher to experimental group.

Group Type EXPERIMENTAL

oral care bundle

Intervention Type OTHER

In the first stage, oral health was evaluated and data about the patient was collected.

In the second stage, an oral care bundle containing an oral care combination was applied to the experimental group. According to this bundle application, patients were received tooth brushing (with chlorhexidine solution) and ice water application twice a day and moisturizing attempts 4 times a day.

In the 3rd stage, saliva pH, dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated.

Measurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip.

Data regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee.

Patients receiving routine clinical oral care

Routine oral care protocol used in intensive care unit was applied to control group by the patient's primary nurse.

Group Type OTHER

clinical oral care

Intervention Type OTHER

In the first stage, oral health was evaluated and data about the patient was collected.

In the second stage, routine oral care protocol used in intensive care unit was applied to patients by the patients' primary nurse. According to this application, patients were received oral care using tongue depressor with wrapped in gauze and chlorhexidine solution 4 times a day.

In the 3rd stage, saliva pH (power of hydrogen), dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated.

Measurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip.

Data regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee.

Interventions

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oral care bundle

In the first stage, oral health was evaluated and data about the patient was collected.

In the second stage, an oral care bundle containing an oral care combination was applied to the experimental group. According to this bundle application, patients were received tooth brushing (with chlorhexidine solution) and ice water application twice a day and moisturizing attempts 4 times a day.

In the 3rd stage, saliva pH, dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated.

Measurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip.

Data regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee.

Intervention Type OTHER

clinical oral care

In the first stage, oral health was evaluated and data about the patient was collected.

In the second stage, routine oral care protocol used in intensive care unit was applied to patients by the patients' primary nurse. According to this application, patients were received oral care using tongue depressor with wrapped in gauze and chlorhexidine solution 4 times a day.

In the 3rd stage, saliva pH (power of hydrogen), dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated.

Measurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip.

Data regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* mechanical ventilation support,
* orally intubation
* in the first 24 hours of intubation,
* stable hemodynamic status

Exclusion Criteria

* pneumonia
* Sjögren's Syndrome,
* radiotherapy and/or chemotherapy,
* oral care contraindications,
* head and neck trauma,
* platelet count below 50 thousand,
* could not be positioned appropriately,
* agitation
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role collaborator

Nigde Omer Halisdemir University

OTHER

Sponsor Role lead

Responsible Party

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Gül Güneş AKTAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gül Güneş AKTAN

Niğde, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Abdelhafez AI, Tolba AA. Nurses' practices and obstacles to oral care quality in intensive care units in Upper Egypt. Nurs Crit Care. 2023 May;28(3):411-418. doi: 10.1111/nicc.12736. Epub 2021 Dec 2.

Reference Type BACKGROUND
PMID: 34855285 (View on PubMed)

Alja'afreh MA, Mosleh SM, Habashneh SS. The Effects of Oral Care Protocol on the Incidence of Ventilation-Associated Pneumonia in Selected Intensive Care Units in Jordan. Dimens Crit Care Nurs. 2019 Jan/Feb;38(1):5-12. doi: 10.1097/DCC.0000000000000334.

Reference Type BACKGROUND
PMID: 30499786 (View on PubMed)

Andersson P, Persson L, Hallberg IR, Renvert S. Testing an oral assessment guide during chemotherapy treatment in a Swedish care setting: a pilot study. J Clin Nurs. 1999 Mar;8(2):150-8. doi: 10.1046/j.1365-2702.1999.00237.x.

Reference Type BACKGROUND
PMID: 10401348 (View on PubMed)

Blot S, Deschepper M, Labeau S. De-adoption of chlorhexidine oral care and ICU mortality. Intensive Care Med. 2022 May;48(5):624-625. doi: 10.1007/s00134-022-06621-4. Epub 2022 Jan 17. No abstract available.

Reference Type BACKGROUND
PMID: 35037992 (View on PubMed)

Chair SY, Chan DWK, Cao X. The interaction of subglottic drainage, cuff pressure, and oral care on endotracheal tube fluid leakage: A benchtop study. Aust Crit Care. 2020 Jul;33(4):358-363. doi: 10.1016/j.aucc.2019.05.002. Epub 2019 Jun 24.

Reference Type BACKGROUND
PMID: 31248697 (View on PubMed)

Cuthbertson BH, Dale CM. Less daily oral hygiene is more in the ICU: yes. Intensive Care Med. 2021 Mar;47(3):328-330. doi: 10.1007/s00134-020-06261-6. Epub 2020 Oct 10. No abstract available.

Reference Type BACKGROUND
PMID: 33037882 (View on PubMed)

Dale CM, Rose L, Carbone S, Pinto R, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Scales DC, Cuthbertson BH. Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial. Intensive Care Med. 2021 Nov;47(11):1295-1302. doi: 10.1007/s00134-021-06475-2. Epub 2021 Oct 5.

Reference Type BACKGROUND
PMID: 34609548 (View on PubMed)

Other Identifiers

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19-5T/40

Identifier Type: -

Identifier Source: org_study_id

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