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Completed

NCT Number: NCT06258603

Oral Care of Intubated Intensive Care Patient

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.

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Key information

Conditions

Pneumonia Dry Mouth Infections Lung Diseases Mechanical Ventilation Complication Mouth Diseases Respiratory Tract Diseases Respiratory Tract Infections Salivary Gland Diseases Salivation Sialorrhea Stomatognathic Diseases Xerostomia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gül Güneş AKTAN

Niğde, Merkez, 51100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral care bundle

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.

clinical oral care

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.

Primary outcomes

  1. Individual Identification Form

    Time frame: First day of data collection

    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).

  2. Bedside Oral Exam Scale

    Time frame: Evaluated for five days.

    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).

  3. In this outcome measure, the patients'vsaliva pH (power of hydrogen) was evaluated.

    Time frame: The 1st, 3rd and 5th days of oral care practices

    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.

  4. In this outcome measure, the patients' saliva amount was evaluated.

    Time frame: The 1st, 3rd and 5th days of oral care practices.

    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.

  5. In this outcome measure, it was evaluated whether ventilator-associated pneumonia occured in patients receiving care.

    Time frame: Evaluated for five days.

    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.

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Collaborators

  • Ege University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Feb 14, 2024
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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