Clinical trial NCT06258603: Oral Care of Intubated Intensive Care Patient
Official title: The Effect of Oral Care Bundle Application on Salivary pH (Power of Hydrogen), Dry Mouth and Ventilator-associated Pneumonia in Intubated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Mechanical Ventilation Complication
Salivation
Dry Mouth
Keywords: oral health
oral care
intensive care
nursing
intubation
dry mouth
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2024-02-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Individual Identification Form
timeFrame: First day of data collection
measure: Bedside Oral Exam Scale
timeFrame: Evaluated for five days.
measure: In this outcome measure, the patients'vsaliva pH (power of hydrogen) was evaluated.
timeFrame: The 1st, 3rd and 5th days of oral care practices
measure: In this outcome measure, the patients' saliva amount was evaluated.
timeFrame: The 1st, 3rd and 5th days of oral care practices.
measure: In this outcome measure, it was evaluated whether ventilator-associated pneumonia occured in patients receiving care.
timeFrame: Evaluated for five days.
Secondary outcomes:
Other outcomes:
Locations:
city: Ni̇ğde
country: Turkey
facility: Gül Güneş AKTAN
state: Merkez
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.