Chlorhexidine vs Lactobacillus Plantarum for Oral Care in Intubated ICU Patients

NCT ID: NCT01105819

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2018-01-31

Brief Summary

Critically ill patients often need ventilatory support through a plastic tube connected to a ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as well as throughout the intestine. Bacteria that can cause illness are often found in the oropharynx in such patients and measures are taken in order to reduce the risk of secondary infections by those bacteria. In all intensive care patients oral care is provided by the nursing staff aiming at a reduction of the pathogenic species. This is done by a variety measures.

Chlorhexidine (CHX) is an antisepticum with a capability to reduce bacterial counts in the mouth and oropharynx and has been shown to be of value also for intubated patients. It is used frequently throughout the world.

Ventilator-associated pneumonia (VAP) is a costly rather frequent complication to intensive care and mechanical ventilation and is usually caused by aspiration of infected secretions from the oropharynx. CHX has in some studies been shown to reduce the frequency of VAP.

The probiotic bacterium Lactobacillus plantarum 299 has the ability to adhere to the mucosa throughout the gastro-intestinal tract including the mouth and in our pilot study we found that L plantarum had better ability to reduce colonisation with enteric bacteria in the oropharynx than CHX had. Figures not statistical significant so this present study is aiming to get a larger amount of data.

The procedure was found to be safe Hypothesis: Lactobacillus plantarum is better than CHX for the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated patients and consequently has a better potential to reduce the frequency of VAP

Detailed Description

This study is an expansion of a pilot study performed at the ICU Lund University Hospital, Sweden where 50 patients were included (ISRCTN00472141).

Results have been published in Critical Care 2008, 12:R136 The protocol is the same and in this second phase we intend to include 100 patients and results will be summed up.

Three centres are engaged. The results from the pilot study is encouraging and we are aiming at getting statistical significance in the differences in pathogenic findings in the cultures from oropharynx and also better a better basis for the calculation of the number of patients needed to get sufficient power to study difference in VAP frequency.

Conditions

Pathogenic Bacteria in the Oropharynx; Ventilator-associated Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard oral care with chlorhexidine

The control group will receive a standard oral care. This includes suction of secretions, brushing of teeth cleansing of the oral cavity with swabs soaked with a chlorhexidine solution. This procedure is performed twice a day. In between, suction whenever needed and cleansing with swabs soaked with carbonated bottled water is performed

Group Type: OTHER

Chlorhexidine for standard oral care

Intervention Type: PROCEDURE

A The control group will receive the standard oral care of the department (general ICU, Lund University Hospital).

This includes suction of secretions, brushing of teeth cleansing of the oral cavity with swabs soaked with a chlorhexidine solution. This procedure is performed twice a day. In between, suction whenever needed and cleansing with swabs soaked with carbonated bottled water is performed Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2,3,5,7,10,14 and 21 or before extubation if this occurs on a non-culture day

Lactobacillus plantarum 299

The study group will be attended in the same manor but the swabs used for cleansing are soaked with carbonated water directly from freshly opened bottles. As the final part of the procedure oral mucosal surfaces are pencilled with a suspension of the probiotic bacterium Lactobacillus plantarum 299 Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2,3,5,7,10,14 and 21 or before extubation if this occurs on a non-culture day

Group Type: ACTIVE_COMPARATOR

Lactobacillus plantarum 299 for oral care

Intervention Type: PROCEDURE

The study group will be attended in the same manor but the swabs used for cleansing are soaked with carbonated water directly from freshly opened bottles. As the final part of the procedure oral mucosal surfaces are pencilled with a suspension of the probiotic bacterium Lactobacillus plantarum 299 Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2,3,5,7,10,14 and 21 or before extubation if this occurs on a non-culture day

Interventions

Lactobacillus plantarum 299 for oral care

The study group will be attended in the same manor but the swabs used for cleansing are soaked with carbonated water directly from freshly opened bottles. As the final part of the procedure oral mucosal surfaces are pencilled with a suspension of the probiotic bacterium Lactobacillus plantarum 299 Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2,3,5,7,10,14 and 21 or before extubation if this occurs on a non-culture day

Intervention Type: PROCEDURE

Chlorhexidine for standard oral care

A The control group will receive the standard oral care of the department (general ICU, Lund University Hospital).

This includes suction of secretions, brushing of teeth cleansing of the oral cavity with swabs soaked with a chlorhexidine solution. This procedure is performed twice a day. In between, suction whenever needed and cleansing with swabs soaked with carbonated bottled water is performed Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2,3,5,7,10,14 and 21 or before extubation if this occurs on a non-culture day

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Critically ill patients anticipated to require mechanical ventilation for at least 24 hours

Exclusion Criteria

• Pneumonia as admission diagnosis,
• Fractures on the facial skeleton or the skull base;
• Known ulcers in the oral cavity, the oropharynx, or the esophagus
• Known immune difficency
• Carrier of HIV or Hepatitis
• Patient being moribund

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

County Council of Halland, Sweden

OTHER_GOV

Sponsor Role: collaborator

Probi AB

INDUSTRY

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Bengt Klarin

Consultant, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Intensive Care Unit, Halmstad Central Hospital

Halmstad, , Sweden

Intensive Care Unit, Kristianstad Central hospital

Kristianstad, , Sweden

Intensive Care Unit, Lund University Hospital

Lund, , Sweden

Countries

Sweden

References

Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.

Reference Type: RESULT

PMID: 18990201 (View on PubMed)

Klarin B, Adolfsson A, Torstensson A, Larsson A. Can probiotics be an alternative to chlorhexidine for oral care in the mechanically ventilated patient? A multicentre, prospective, randomised controlled open trial. Crit Care. 2018 Oct 28;22(1):272. doi: 10.1186/s13054-018-2209-4.

Reference Type: DERIVED

PMID: 30368249 (View on PubMed)

Other Identifiers

PROHYG 1B

Identifier Type: -

Identifier Source: org_study_id