Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
24/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Caroline Allison

ORCID ID

Contact details

Epsom & St Helier University Hospital NHS Trust
ITU General Hospital
Dorking Road
Epsom
KT18 7EG
United Kingdom
+44 (0)1372 735210

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0112173777

Study information

Scientific title

Acronym

Study hypothesis

Patients on ventilators in intensive therapy units (ITUs) are dependent on nursing staff for oral hygiene. Early onset ventilator associated pneumonia occurs 48-72 hours after insertion of an endotracheal tube. There are several factors involved in this. One is poor oral hygiene. This is because bacteria contributing to pneumonia may colonise teeth. These bacteria are then aspirated into the chest. Pneumonia may follow this. The principle question is whether improving oral hygiene by brushing the teeth more frequently than normal will reduce the number of bacteria in the upper airway. If so, it may reduce rates of pneumonia. Hypothesis: good oral hygiene reduces colonisation of the airway.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Oral Health: Ventilator associated pneumonia

Intervention

Twenty patients will be randomised to one of two groups. Twenty envelopes will contain ten labels for each group. Either control or enhanced. These will be shuffled into a random order, then labelled 1 to 20. As each patient is admitted, their group will be decided by sequential envelopes containing the randomised group name. Envelope one will be used first, then envelope two and so forth.

The control group patients will receive the ITC standard oral hygiene. That is, teeth brushed twice per day, in the morning and evening with a small toothbrush and toothpaste. The toothbrush and toothpaste will be identical for each patient. Oropharyngeal suction will be performed by nursing staff as required using a Yankaur suction device. Foam swabs wet with water will be used in between times for comfort.

The enhanced care group will receive the standard oral care as described, but will have their teeth brushed four times per day at 6 hourly intervals. Oropharyngeal suction will be provided as required as will wet foam swabs for comfort. If untoward bleeding of the gums occurs in participants, they may be withdrawn from the trial.
Each patient will have an oral/dental swab taken on admission. The sterile swab will be wiped around all facets of the teeth and gums that are accessible. The participant will also have a sputum specimen taken. This will be aspirated from the endotracheal tube using a closed system suction device and specimen trap. The participant will be preoxygenated before the procedure to prevent instability of their condition. The procedure will only be carried out at a time when aspiration of sputum from the chest is already indicated as part of the normal treatment. Both these procedures will be carried out by registered physiotherapists who will be blinded to the treatment group of the participant. Specimens will be anonymised as each patient will be allocated a number at the beginning of the study. The specimens will be sent to the microbiology dept. for analysis before being destroyed.

Oral swabs and sputum samples will be collected from each participant on day 0, day 3, day 6, and day 10 for analysis. Nursing staff will be trained in the method of oral hygiene to be used. Physiotherapists will be trained in the specific way in which to take swabs and sputum samples in order to standardise the procedure. Both groups of staff perform these procedures as part of their normal job.

Patients will be followed for a maximum of 10 days after inclusion, Standard demographic information will be recorded including gender, age, diagnosis requiring ITU and ventilatory support. The severity of illness score will also be noted (APACHE 11 score). Throughout the days temperature will be recorded at 4 hourly intervals as normal. Any spike in temperature above 38 degrees centigrade will be noted, as will any change in antibiotic therapy. A score of the condition of the patient's mouth will also be made( tool to be confirmed).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Levels of bacterial colonisation in the upper respiratory tract over the ten day period measured as numbers of colony forming units. Comparison between the control and enhanced care group.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/11/2005

Overall trial end date

15/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible patients are to be enrolled between 12/05 and 03/06 from Epsom and St Helier Hospital ITUs. The study will be a prospective blind randomised controlled trial. Approval from the Research Ethics Committee and Research and Development are being sought.

Patients admitted to the ITU for mechanical ventilation will be invited to join the study as long as they fulfill the following criteria: all adult patients, male and female aged 18 to 95 with written consent. This may be obtained from the participant or from a legal representative or next of kin. Participants must have been intubated within the hospital. However, if intubated in another hospital they may be included as long as they arrive in the ITU within 12 hours of intubation. Participants must not be endentulous or have a tracheostomy tube. Patients with both medical and surgical diagnosis will be included but their condition must suggest an expected admission period of more that 8 days.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Edentulous patients
2. Patients with a facial injury
3. Patients with a tracheostomy tube

Recruitment start date

17/11/2005

Recruitment end date

15/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Epsom & St Helier University Hospital NHS Trust
Epsom
KT18 7EG
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Epsom and St Helier University Hospitals NHS Trust (UK) - NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes