Oral Care of Intubated Intensive Care Patient

Pneumonia Clinical Trial

Official title:

The Effect of Oral Care Bundle Application on Salivary pH (Power of Hydrogen), Dry Mouth and Ventilator-associated Pneumonia in Intubated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06258603
• Other study ID #: 19-5T/40
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: June 19, 2023

Study information

• Verified date: February 2024
• Source: Nigde Omer Halisdemir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 19, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Mouth
• Mechanical Ventilation Complication
• Pneumonia
• Salivation
• Xerostomia

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Gül Günes AKTAN	Ni?gde	Merkez

Sponsors (2)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University	Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual Identification Form	The form was prepared by the researcher in line with literature information. It consists of 9 questions covering the characteristics of the patients (demographic characteristics, diagnoses, APACHE II scores, Glasgow Coma Scale score, rules, feeding patterns, intubation tube number).	First day of data collection
Primary	Bedside Oral Exam Scale	Oral health was assessed using the scale. The scale consists of 8 subheadings (swallowing, lips, tongue, saliva, mucous membranes, gums, teeth or dentures, and smell). The scale score ranges from 8 points (perfect oral health) to 24 points (impaired oral health).	Evaluated for five days.
Primary	In this outcome measure, the patients'vsaliva pH (power of hydrogen) was evaluated.	Merck brand Universal pH 0-14 indicator was used to measure the saliva pH of the patients. The indicator was placed on the tongue and waited for 1 minute, and the resulting color change was compared with the color scale on the box. According to the literature, the average pH of unstimulated saliva has been determined to be approximately 6.8.	The 1st, 3rd and 5th days of oral care practices
Primary	In this outcome measure, the patients' saliva amount was evaluated.	Schirmer Tear Test Strip was used in the application. The Modified Schirmer Test strip was placed under the tongue by holding its end with forceps, and after waiting for 3 minutes, the mm value of the wetness on the strip was read.	The 1st, 3rd and 5th days of oral care practices.
Primary	In this outcome measure, it was evaluated whether ventilator-associated pneumonia occured in patients receiving care.	To avoid bias regarding the method used, the diagnosis of ventilator associated pneumonia was made independently by the treatment team. In the Intensive Care Unit of Ege University Faculty of Medicine, Department of Anesthesiology and Reanimation, the diagnosis of ventilator associated pneumonia is made by the physician using the nosocomial infection diagnostic criteria of The Centers for Disease Control and Prevention (CDC). Information about the development of ventilator associated pneumonia was obtained from the infection control nurse.	Evaluated for five days.