Effects of Oral Care in the Neuroscience ICU

NCT ID: NCT00518752

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with neurological dysfunction requiring intubation and ventilation are at risk for developing ventilator acquired pneumonia. Several studies have suggested that oral hygiene plays a role in the subsequent development of pneumonia for patients in the intensive care unit requiring intubation and mechanical ventilation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventilator Associated Pneumonia Oral Hygiene

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Standard Oral Care

Group Type ACTIVE_COMPARATOR

Standard Oral Care

Intervention Type PROCEDURE

Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day

B

Comprehensive Oral Care

Group Type EXPERIMENTAL

Comprehensive Oral Care

Intervention Type PROCEDURE

Patients will receive a comprehensive oral care protocol using mechanical brushes and oral care products formulated for patients with a dry mouth twice a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard Oral Care

Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day

Intervention Type PROCEDURE

Comprehensive Oral Care

Patients will receive a comprehensive oral care protocol using mechanical brushes and oral care products formulated for patients with a dry mouth twice a day

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \> or equal 18 years old
* Intubated within 24hours of admission to the Neuroscience ICU
* Intubation anticipated to continue for approximately 72 hours

Exclusion Criteria

* Minors
* Pregnancy
* Acute cervical spinal cord injury
* Severe facial trauma
* Family not present for consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lund University

OTHER

Sponsor Role collaborator

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Virginia C Prendergast, MSN, NP-C

Role: PRINCIPAL_INVESTIGATOR

St Joseph's Hospital and Medical Center, Phoenix, Arizona, USA

Ingalill R Hallberg, PhD

Role: STUDY_CHAIR

Vardalinstitutet, University of Lund, Sweden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Munro CL, Grap MJ. Oral health and care in the intensive care unit: state of the science. Am J Crit Care. 2004 Jan;13(1):25-33; discussion 34.

Reference Type BACKGROUND
PMID: 14735645 (View on PubMed)

Dennesen P, van der Ven A, Vlasveld M, Lokker L, Ramsay G, Kessels A, van den Keijbus P, van Nieuw Amerongen A, Veerman E. Inadequate salivary flow and poor oral mucosal status in intubated intensive care unit patients. Crit Care Med. 2003 Mar;31(3):781-6. doi: 10.1097/01.CCM.0000053646.04085.29.

Reference Type BACKGROUND
PMID: 12626984 (View on PubMed)

Prendergast V, Hagell P, Hallberg IR. Electric versus manual tooth brushing among neuroscience ICU patients: is it safe? Neurocrit Care. 2011 Apr;14(2):281-6. doi: 10.1007/s12028-011-9502-2.

Reference Type DERIVED
PMID: 21249529 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07NU018-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.