Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453122
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-07
Brief Title:
Effect of Toothbrushing Without Chlorhexidine on Oral Hygiene Indices in Patients With Orotracheal Intubation
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Effect of Toothbrushing Without Chlorhexidine on Oral Hygiene Indices and Risks of Systemic Complications in Patients With Orotracheal Intubation Randomized Pilot Clinical Study and Cost-effectiveness Analysis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Detailed Description:
Chlorhexidine group Oral hygiene will be carried out in accordance with the standard operating procedures already carried out for all patients admitted to the ICU First the secretion contained in the oral cavity will be aspirated with a suction probe or a dental sucker or the suction brush itself before starting the oral hygiene procedure The hygiene process will begin by moistening the oral cavity using non-sterile gauze soaked in filtered mineral water and applying it to the entire oral mucosa Subsequently the sucking toothbrush or oral swab should be moistened frequently with 012 chlorhexidine digluconate solution and proceed with cleaning the dental surfaces on their buccal palatal and occlusal surfaces moving towards the oral cavity and tongue using the bristle part of the toothbrush With the region opposite the dental bristles or oral swab the 012 chlorhexidine solution will be applied to the oral mucosa palate tongue dorsum and orotracheal tube always performing a postero-anterior movement and removing any dirt with the aid of moistened gauze The oral cavity will be constantly vacuumed throughout the oral hygiene procedure Finally the lips will be lubricated with a standardized lip moisturizer The procedure will be carried out every 8 hours that is three times a day
Water group The intervention group procedure will be carried out in the same way and frequency as the control group however replacing the 012 chlorhexidine solution with mineral water Oral hygiene will be carried out by the nursing team who will be blind to the indices to be evaluated The team will be previously trained to carry out hygiene procedures by the ICU team of dental surgeons
Water group The intervention group procedure will be carried out in the same way and frequency as the control group however replacing the 012 chlorhexidine solution with mineral water Oral hygiene will be carried out by the nursing team who will be blind to the indices to be evaluated The team will be previously trained to carry out hygiene procedures by the ICU team of dental surgeons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None