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
NCT number | NCT06258603 |
Other study ID # | 19-5T/40 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | June 19, 2023 |
Verified date | February 2024 |
Source | Nigde Omer Halisdemir University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Gül Günes AKTAN | Ni?gde | Merkez |
Lead Sponsor | Collaborator |
---|---|
Nigde Omer Halisdemir University | Ege University |
Turkey,
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
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. |
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