Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units

NCT07129733 | Not Yet Recruiting

• 1 other identifier: ip_hcor_oracle
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of the ORACLE study is to evaluate the impact of implementing a standardized oral hygiene bundle on outcomes in critically ill, mechanically ventilated patients. The primary objective is to determine whether this bundle can increase the number of ventilator-free days compared to the standard of care.

Conditions

Mechanical Ventilation; Infection Prevention; Oral Care; Oral Hygiene, Oral Health; VAP - Ventilator Associated Pneumonia

Keywords

Oral care; Oral hygiene; critically ill; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Ventilator free days

  Days alive and free from mechanical ventilation

  28 days after enrollment

Secondary Outcomes (5)

• Intensive Care Unit all cause mortality

  15 months

• Hospital all cause mortality

  15 months

• Ventilator associated pneumonia incidence

  15 months

• Intensive care unit free days

  28 days after enrollment

• Hospital free days

  28 days after enrollment

Study Arms (2)

Oral hygiene bundle

EXPERIMENTAL

This arm will receive the standardized oral hygiene bundle

Other: Oral hygiene bundle

Standard of care

NO INTERVENTION

Each center will maintain its usual oral care practices.

Interventions

Oral hygiene bundle OTHER

Implementation of the standardized oral hygiene bundle, which consists of the following key components: Standardization of materials used during the oral hygiene procedure, standardization of oral hygiene frequency, training of nursing staff involved in patient care on proper oral hygiene practices, discontinuation of routine application of chlorhexidine oral solution, and implementation of a standardized oral hygiene technique.

Oral hygiene bundle

Eligibility Criteria

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

You may qualify if:

• All patients who receive mechanical ventilation in the participating intensive care units

Sponsors & Collaborators

• Hospital do Coracao: lead
• Faculdade de Medicina de Ribeirão Preto/USP: collaborator

Study Sites (6)

Santa Casa de Misericordia de Passos

Passos, Minas Gerais, Brazil

Location

Hospital Municipal de Maringa

Maringá, Paraná, Brazil

Location

Hospital da Restauracao

Recife, Pernambuco, Brazil

Location

Hospital Santa Cruz

Santa Cruz, Rio Grande do Sul, Brazil

Location

Hospital Nereu Ramos

Florianópolis, Santa Catarina, Brazil

Location

Hospital Leo Orsi

Itapetininga, São Paulo, Brazil

Location

Related Publications (10)

• 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.

  PMID: 34609548 RESULT

• Price R, MacLennan G, Glen J; SuDDICU Collaboration. Selective digestive or oropharyngeal decontamination and topical oropharyngeal chlorhexidine for prevention of death in general intensive care: systematic review and network meta-analysis. BMJ. 2014 Mar 31;348:g2197. doi: 10.1136/bmj.g2197.

  PMID: 24687313 RESULT

• Bellissimo-Rodrigues WT, Menegueti MG, Gaspar GG, de Souza HCC, Auxiliadora-Martins M, Basile-Filho A, Martinez R, Bellissimo-Rodrigues F. Is it necessary to have a dentist within an intensive care unit team? Report of a randomised clinical trial. Int Dent J. 2018 Dec;68(6):420-427. doi: 10.1111/idj.12397. Epub 2018 May 18.

  PMID: 29777534 RESULT

• Bellissimo-Rodrigues F, Bellissimo-Rodrigues WT. Ventilator-associated pneumonia and oral health. Rev Soc Bras Med Trop. 2012 Oct;45(5):543-4. doi: 10.1590/s0037-86822012000500001. No abstract available.

  PMID: 23152333 RESULT

• 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 RESULT

• 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 RESULT

• Marino PJ, Wise MP, Smith A, Marchesi JR, Riggio MP, Lewis MAO, Williams DW. Community analysis of dental plaque and endotracheal tube biofilms from mechanically ventilated patients. J Crit Care. 2017 Jun;39:149-155. doi: 10.1016/j.jcrc.2017.02.020. Epub 2017 Feb 16.

  PMID: 28259058 RESULT

• van Nieuwenhoven CA, Buskens E, Bergmans DC, van Tiel FH, Ramsay G, Bonten MJ. Oral decontamination is cost-saving in the prevention of ventilator-associated pneumonia in intensive care units. Crit Care Med. 2004 Jan;32(1):126-30. doi: 10.1097/01.CCM.0000104111.61317.4B.

  PMID: 14707570 RESULT

• Magill SS, Edwards JR, Bamberg W, Beldavs ZG, Dumyati G, Kainer MA, Lynfield R, Maloney M, McAllister-Hollod L, Nadle J, Ray SM, Thompson DL, Wilson LE, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Multistate point-prevalence survey of health care-associated infections. N Engl J Med. 2014 Mar 27;370(13):1198-208. doi: 10.1056/NEJMoa1306801.

  PMID: 24670166 RESULT

• Dasta JF, McLaughlin TP, Mody SH, Piech CT. Daily cost of an intensive care unit day: the contribution of mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1266-71. doi: 10.1097/01.ccm.0000164543.14619.00.

  PMID: 15942342 RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Critical Illness

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando Belissimo-Rodrigues, MD, PhD

  Faculdade de Medicina de Ribeirão Preto da USP

  STUDY CHAIR

• Bruno M Tomazini, MD

  Hospital do Coração (Hcor)

  PRINCIPAL INVESTIGATOR

• Wanessa Belissimo-Rodrigues, PhD

  Faculdade de Medicina de Ribeirão Preto da USP

  STUDY CHAIR

• Alexandre Biasi Cavalcanti, MD, PhD

  Hospital do Coração (Hcor)

  STUDY DIRECTOR

Central Study Contacts

Bruno M Tomazini, MD

CONTACT

+5511982839173; btomazini@hocr.com.br

Wanessa Belissimo-Rodrigues, PhD

CONTACT

+111699963-8236‬; wanessatbr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is a stepped wedge cluster randomized clinical trial, with a 11-month transition period between interventions.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: August 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after study completion
• Access Criteria: Individual patient data might be shared upon request and approval by the study committee after the study completion.

Locations

BR (6)