Mechanical VentilationORACLENCT07129733
Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units
A study testing Oral hygiene bundle in people with Mechanical Ventilation and Infection Prevention, run by Hospital do Coracao at 6 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Infection Prevention, Oral Care
- What is being tested?
- Oral hygiene bundle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 6 sitesBrazil
- Study dates
- 1 Sep 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who receive mechanical ventilation in the participating intensive care units
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Brazil6 sites
Hospital Nereu Ramos
Florianópolis, Santa Catarina
Israel S. Maia
Hospital Leo Orsi
Itapetininga, São Paulo
Vivian Irineu
Hospital Municipal de Maringa
Maringá, Paraná
Francielle Pereira
Santa Casa de Misericordia de Passos
Passos, Minas Gerais
Priscila Goncalves
Hospital da Restauracao
Recife, Pernambuco
Debora Pinho
Hospital Santa Cruz
Santa Cruz, Rio Grande do Sul
Maite Magdalena
About this study
Official title: Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units: A Stepped-Wedge Cluster Randomized Clinical Trial
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.
Read the detailed description
The use of invasive mechanical ventilation (IMV) as an organ support measure is common in intensive care units (ICUs), with its prevalence ranging from 36% to 89%. Lower respiratory tract infections (LRTIs) are known to be the primary site of infection related to sepsis in critically ill patients in Brazilian ICUs and are associated with high morbidity and mortality.
It is well established that the oral cavity is a source of pathogens leading to LRTIs in critically ill patients, with dental plaque serving as an important reservoir of these pathogens. Therefore, oral hygiene in critically ill patients is an essential measure for the prevention of LRTIs, as recommended by both international and national guidelines.
Simple cleaning of the oral cavity using a toothbrush or oral swab, in addition to providing comfort and well-being to the patient, contributes to the prevention of LRTIs and other infections. A recent meta-analysis evaluating the impact of standardized toothbrushing on clinical outcomes showed that this care intervention was associated with a lower incidence of LRTIs and reduced mortality. On the other hand, an international clinical trial demonstrated that the implementation of an oral care bundle combined with the de-implementation of chlorhexidine for oral care was not associated with improved outcomes.
Based on the rationale supporting the benefits of implementing a standardized oral care, findings from previous studies, the conflicting literature regarding the effectiveness of oral care protocols that include the de-implementation of chlorhexidine on clinical outcomes in ICU patients, and the scarcity of data from developing countries such as Brazil, conducting a clinical trial is needed.
- Conditions
- Mechanical Ventilation, Infection Prevention, Oral Care, Oral Hygiene, Oral Health, VAP - Ventilator Associated Pneumonia
- Being tested
- Oral hygiene bundle
- Keywords
- Oral care, Oral hygiene, critically ill, mechanical ventilation
- Medical subject headings
- Pneumonia, Ventilator-Associated, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene bundleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral hygiene bundle | Experimental | This arm will receive the standardized oral hygiene bundle Receives: Other: Oral hygiene bundle |
| Standard of care | No intervention | Each center will maintain its usual oral care practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days
Days alive and free from mechanical ventilation
Measured: 28 days after enrollment
Secondary outcomes (5)
Intensive Care Unit all cause mortality
All cause mortality during intensive care unit stay
Measured: 15 months
Hospital all cause mortality
All cause mortality during hospital stay
Measured: 15 months
Ventilator associated pneumonia incidence
Defined as the number of ventilator associated pneumonia cases adjusted per ventilated-patients/days
Measured: 15 months
Intensive care unit free days
Days alive and free from intensive care unit
Measured: 28 days after enrollment
Hospital free days
Days alive and free from hospital
Measured: 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a stepped wedge cluster randomized clinical trial, with a 11-month transition period between interventions.
- Masking
- None (open label)
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Medicina de Ribeirão Preto/USP
- Responsible party
- Principal investigator, Bruno Martins Tomazini, Hospital do Coracao
- Investigators
- Fernando Belissimo-Rodrigues, MD, PhD, Study chair, Faculdade de Medicina de Ribeirão Preto da USPBruno M Tomazini, MD, Principal investigator, Hospital do Coração (Hcor)Wanessa Belissimo-Rodrigues, PhD, Study chair, Faculdade de Medicina de Ribeirão Preto da USPAlexandre Biasi Cavalcanti, MD, PhD, Study director, Hospital do Coração (Hcor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129733
- Sponsor's protocol ID
- ip_hcor_oracle
- Acronym
- ORACLE
- Status last verified
- Aug 2025
- First submitted
- 28 May 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data (IPD) might be shared upon request and approval by the study committee after the study completion.
Publications
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.
PubMed 34609548Price 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.
PubMed 24687313Bellissimo-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.
PubMed 29777534Bellissimo-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.
PubMed 23152333Zhao 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.
PubMed 33368159Klompas 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.
PubMed 35589091Marino 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.
PubMed 28259058van 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.
PubMed 14707570Magill 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.
PubMed 24670166Dasta 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.
PubMed 15942342
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units: A Stepped-Wedge Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07129733
- Acronym / sponsor ID
- ORACLE / ip_hcor_oracle
- Conditions
- Mechanical Ventilation, Infection Prevention, Oral Care, Oral Hygiene, Oral Health, VAP - Ventilator Associated Pneumonia
- Keywords
- Oral care, Oral hygiene, critically ill, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Faculdade de Medicina de Ribeirão Preto/USP
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of invasive mechanical ventilation (IMV) as an organ support measure is common in intensive care units (ICUs), with its prevalence ranging from 36% to 89%. Lower respiratory tract infections (LRTIs) are known to be the primary site of infection related to sepsis in critically ill patients in Brazilian ICUs and are associated with high morbidity and mortality.
It is well established that the oral cavity is a source of pathogens leading to LRTIs in critically ill patients, with dental plaque serving as an important reservoir of these pathogens. Therefore, oral hygiene in critically ill patients is an essential measure for the prevention of LRTIs, as recommended by both international and national guidelines.
Simple cleaning of the oral cavity using a toothbrush or oral swab, in addition to providing comfort and well-being to the patient, contributes to the prevention of LRTIs and other infections. A recent meta-analysis evaluating the impact of standardized toothbrushing on clinical outcomes showed that this care intervention was associated with a lower incidence of LRTIs and reduced mortality. On the other hand, an international clinical trial demonstrated that the implementation of an oral care bundle combined with the de-implementation of chlorhexidine for oral care was not associated with improved outcomes.
Based on the rationale supporting the benefits of implementing a standardized oral care, findings from previous studies, the conflicting literature regarding the effectiveness of oral care protocols that include the de-implementation of chlorhexidine on clinical outcomes in ICU patients, and the scarcity of data from developing countries such as Brazil, conducting a clinical trial is needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a stepped wedge cluster randomized clinical trial, with a 11-month transition period between interventions.
| Arm | Type | Receives |
|---|---|---|
| Oral hygiene bundle | Experimental | Other: Oral hygiene bundleThis arm will receive the standardized oral hygiene bundle |
| Standard of care | No intervention | –Each center will maintain its usual oral care practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who receive mechanical ventilation in the participating intensive care units
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral hygiene bundleImplementation 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. | Other | Oral hygiene bundle |
Primary outcome
Ventilator free days
Time frame: 28 days after enrollment
Days alive and free from mechanical ventilation
5 secondary outcomes
Intensive Care Unit all cause mortality
Time frame: 15 months
Hospital all cause mortality
Time frame: 15 months
Ventilator associated pneumonia incidence
Time frame: 15 months
Intensive care unit free days
Time frame: 28 days after enrollment
Hospital free days
Time frame: 28 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Results publication: PubMed 34609548Dale 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.
- Results publication: PubMed 24687313Price 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.
- Results publication: PubMed 29777534Bellissimo-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.
- Results publication: PubMed 23152333Bellissimo-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.
- Results publication: PubMed 33368159Zhao 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.
- Results publication: PubMed 35589091Klompas 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.
- Results publication: PubMed 28259058Marino 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.
- Results publication: PubMed 14707570van 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.
- Results publication: PubMed 24670166Magill 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.
- Results publication: PubMed 15942342Dasta 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.
- Individual participant dataSharing planned: Yes. Individual patient data (IPD) might be shared upon request and approval by the study committee after the study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Belissimo-Rodrigues, MD, PhD study chair
Faculdade de Medicina de Ribeirão Preto da USP
Bruno M Tomazini, MD principal investigator
Hospital do Coração (Hcor)
Wanessa Belissimo-Rodrigues, PhD study chair
Faculdade de Medicina de Ribeirão Preto da USP
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hygiene bundle in people with Mechanical Ventilation and Infection Prevention, run by Hospital do Coracao at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno M Tomazini, MD (+5511982839173, btomazini@hocr.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator free days (time frame: 28 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07129733, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.