Clinical trial NCT06193512: Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study
Official title: Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study (EASIER PILOT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Bacterial Infection
Mechanical Ventilation Complication
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Swiftsure
First posted: 2024-01-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: PREVENTION

Brief summary: We propose a randomized pilot/feasibility study comparing oral care treatment as usual (TAU) with Swiftsure SwishKit plus oral care TAU on the presence and magnitude of bacterial load in the oropharyngeal space in orotracheally intubated patients. The trial will be conducted with IRB approval and written consent from patient or its legal representative.

Detailed description: Qualifying patients will be assigned on a 1:2 (control : treatment intervention) basis using computer-generated codes and random block sizes without stratification to the following groups:

* Oral care TAU
* Swiftsure SwishKit oral flush plus oral care Treatment as Usual (SK+Oral care TAU)

In the Oral care TAU group, oral care will be delivered per standard operating procedure of the ICU, which may include the instillation of chemical agents for the purpose of reducing bacterial load, will be administered at 4-hour intervals, and tooth brushing performed twice daily (morning and evening). In the SK+Oral care TAU group, instillation of chemical antimicrobial agents care and tooth brushing will be performed as in Oral Care TAU, but SwishKit care will be conducted after other oral care interventions, and prior to instillation of the chemical antimicrobial agent. In both groups, treatment will be conducted for up to 5 days, or until extubation.

Detailed interventions:

Oral care TAU (Treatment as Usual) Standard oral care procedures are designed to help remove microorganisms from mouth surfaces and represent a comprehensive suite of interventions. Oral care provision is codified in a written oral care protocol at the Critical Care unit. The Association of Critical Care Nurses calls for oral care every 2-4 hours. This protocol calls for oral care provision at 4-hour intervals. Oral hygiene will consist of assessment of any plaque buildup on teeth or presence of infection. Brushing and cleaning of the mouth surfaces, followed by administration of a moisturizer to the oral mucosa and lips is required. Oral care includes an assessment of the patient on admission to identify oral health status and self-care deficiencies for further action. Dental plaque removal by brushing the teeth with a soft toothbrush at least twice a day is intended to help remove dental plaque. A toothpaste to assist in breakdown of mucous and biofilm can be administered during brushing. Specific to TAU, nursing will help maintain saliva production to minimize mucositis. The head of the bed will be elevated to at least 30° and positioned to allow secretions to pool in the buccal pocket (especially during tooth brushing and feeding), and the provision of sub-glottic suctioning as needed dependent on mucous production.

SwishKit + Oral care TAU The SwishKit device will be used in accordance with the Operators Manual. The SwishKit device will be inserted into the mouth of the patient by a nurse, and the patient will be properly positioned before use of the device.

A total of 60 mL of 0.9% NaCl will be instilled using three x 20 mL aliquots delivered by syringe (syringe inlet), and immediately evacuated by suction. Upon completion, the SwishKit will be removed and disposed of. The nurse will assure that there is no residual saline or other fluid in the mouth or upper airway, and original position for care resumed.

Eligibility criteria: Inclusion Criteria:

* Adults, 18 years or older
* Individual or legally authorized representative consent
* Intubated with an oral endotracheal tube and expected to remain intubated for at least 2 days.

Exclusion Criteria:

* Maxillofacial trauma (current maxillofacial trauma precluding standard oral care techniques)
* Conditions precluding lateral Trendelenburg positioning (e.g., increased intracranial pressure, spinal instability, hemodynamic instability)
* Oropharyngeal injury or infection
* Orofacial edema precluding access for oral care
* Known or anticipated difficult intubation
* Endotracheal cuff air leak that clinicians believe precludes mouth lavage
* Already intubated for more than 24 continuous hours within a week before enrollment.

Primary outcomes:
measure: Bacterial load in the oropharyngeal space
timeFrame: Within 5 days after enrolment.
Secondary outcomes:
measure: Colony-Forming Units/milliliter (ml) (CFU/ml)
timeFrame: Within 5 days after enrolment.
measure: 16S rRNA sequencing of bacteria
timeFrame: Within 5 days after enrolment.
measure: Colony-Forming Units/milliliter (ml) (CFU/ml) and 16S rRNA
timeFrame: Within 2 days after enrolment
Other outcomes:
measure: Clinician Perception of Treatment Use/Efficacy
timeFrame: Within 5 days after enrolment.
measure: Feasibility aims
timeFrame: Within 5 days after enrolment.
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Marcelo Gama de Abreu, MD
role: PRINCIPAL_INVESTIGATOR
References: