Effect of Toothbrushing Without Chlorhexidine on Oral Hygiene Indices in Patients With Orotracheal Intubation

NCT06453122 | Recruiting DMC

• 1 other identifier: 5736-23
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The oral hygiene method commonly used in intubated patients orotracheal is tooth brushing (mechanical removal) and washing the oral cavity and the orotracheal tube (TOT) with digluconate solution chlorhexidine (CLX). However, recent studies have demonstrated that the use of CLX in these conditions may expose the patient to a potential increased risk of mortality. Recent recommendations made by international bodies related to hospital biosafety no longer include the use of CLX in ICU oral hygiene routine. A question not yet answered in the literature is whether the absence of CLX in the critical patient's oral hygiene routine predisposes increased accumulation of dental plaque or microbial colonization related to the risk of systemic complications, such as pneumonia and sepsis. The cost-effectiveness of this protocol change also needs to be evaluated, as the withdrawal of CLX may result in changes in the risk profile morbidity and mortality during hospitalization. The present study aims to investigate whether brushing the oral cavity with mineral water changes the pattern of biofilm accumulation and clinical appearance of the oral mucosa in relation to brushing done with CLX. Microbiological analysis of the oropharyngeal biofilm and cost-effectiveness impact assessment will also be carried out.

Conditions

Oral Hygiene; Intensive Care; Chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Analyze oral cavity brushing

  Analyze oral cavity brushing done with mineral water in the ICU in regarding the accumulation of biofilm and the appearance of the oral mucosa and compare these variables with brushing done with CLX.

  T0 (baseline) - first day of intubation; • T1 - after 3 days of intubation or immediately after extubation (with a minimum of 1 day of intubation); • T2 - after 7 days of intubation (if you still remain intubated).

Study Arms (2)

Chlorhexidine

ACTIVE COMPARATOR

patients with oral hygiene performed with tooth brushing and washing with 0.12% chlorhexidine

Other: Oral care

Water

SHAM COMPARATOR

patients with oral hygiene performed with tooth brushing and washing with filtered water.

Other: Oral care

Interventions

Oral care OTHER

The intervention group procedure will be carried out in the same way and frequency of the control group, however, replacing the chlorhexidine solution 0.12% for mineral water. Oral hygiene will be carried out by the nursing team, which will be blind to the indices to be evaluated. The team will be previously trained to carry out hygiene procedures by the team of ICU dental surgeons.

Chlorhexidine; Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients admitted to the adult ICU;
• age over 18;
• both sexes;
• orotracheal intubation monitored from the first day;
• absence of foci of infection in the oral cavity (periapical lesions,
• periodontal abscesses, extensive cavities, opportunistic infections);
• presence of at least five teeth per dental arch

You may not qualify if:

• patients in whom oral hygiene is not possible;
• patients extubated before 24 hours from baseline;
• patients with foci of infection in the oral cavity present in the baseline moment;
• patients who died before 24 hours from baseline;
• patients whose guardians do not authorize the research to be carried out;
• patients whose information about oral and general health and other study variables are not available in the medical record, are doubtful or not capable of collection.
• patients after heart surgery
• patients with reintubation

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Hospital israelita Albert Einstein

São Paulo, 05652-900, Brazil

RECRUITING

Related Publications (5)

• Klompas M, Branson R, Cawcutt K, Crist M, Eichenwald EC, Greene LR, Lee G, Maragakis LL, Powell K, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia, ventilator-associated events, and nonventilator hospital-acquired pneumonia in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2022 Jun;43(6):687-713. doi: 10.1017/ice.2022.88. Epub 2022 May 20.

  PMID: 35589091 BACKGROUND

• Klompas M, Branson R, Eichenwald EC, Greene LR, Howell MD, Lee G, Magill SS, Maragakis LL, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S133-54. doi: 10.1017/s0899823x00193894. No abstract available.

  PMID: 25376073 BACKGROUND

• Prendergast V, Kleiman C, King M. The Bedside Oral Exam and the Barrow Oral Care Protocol: translating evidence-based oral care into practice. Intensive Crit Care Nurs. 2013 Oct;29(5):282-90. doi: 10.1016/j.iccn.2013.04.001. Epub 2013 May 20.

  PMID: 23702324 BACKGROUND

• Bellissimo-Rodrigues WT, Menegueti MG, de Macedo LD, Basile-Filho A, Martinez R, Bellissimo-Rodrigues F. Oral mucositis as a pathway for fatal outcome among critically ill patients exposed to chlorhexidine: post hoc analysis of a randomized clinical trial. Crit Care. 2019 Nov 27;23(1):382. doi: 10.1186/s13054-019-2664-6. No abstract available.

  PMID: 31775844 BACKGROUND

• Zhao T, Wu X, Zhang Q, Li C, Worthington HV, Hua F. Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia. Cochrane Database Syst Rev. 2020 Dec 24;12(12):CD008367. doi: 10.1002/14651858.CD008367.pub4.

  PMID: 33368159 BACKGROUND

MeSH Terms

Interventions

Dental Care Team

Intervention Hierarchy (Ancestors)

Patient Care Team; Patient Care Management; Health Services Administration

Study Officials

• Fernanda de P Eduardo

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda P Eduardo, PhD

CONTACT

5511999037553; fpeduard@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 11, 2024
• Study Start: March 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)