Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

Not Applicable

Completed

• Conditions: Oropharyngeal Microbiology
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT01521650
• Lead Sponsor: Region Skane

Brief Summary

Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.

Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick and patients with more severe problems.

For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this is a pilot study to explore the possibility of the same kind of positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.

Randomisation

* No prophylaxis

* Preparation with a probiotic suspension before intubation.

Cultures

* oropharynx

* before treatment

* after intubation

* before extubation

* day 1 postoperatively

* tracheal secretions

* after intubation

* before extubation

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-28
• Study First Posted: 2012-01-31
• Primary Completion: 2019-03
• Study Completion: 2020-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Adult patients
• Planned interventions
• Anaesthesia > 4 hours and requiring intubation

Exclusion Criteria

• Ulcers in the mouth, oropharynx, oesophagus and stomach
• Current infections in the airways
• Known immuno deficiences
• Emergency cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics	Patients will gurgle and swallow a mixture of probiotic bacteria

Primary Outcome Measures

Name	Time	Method
Differences in pathogenic bacteria in the oropharynx and lower airways	During hospitalization, up to 4 weeks	Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in conection with anaestesia and a surgical intervention

Secondary Outcome Measures

Name	Time	Method
Pneumonia	Up till 7 days postoperatively	X-ray verified infiltrations in combination with expectorates
Length of hospital stay	time to discharged from hospital or patients death	Comparison of length of stay between the intervention group and the control group
CRP	During hospitalization, up to 4 weeks	CRP taken pre-op and days 1,2,3 post-op
White blood cells	During hospitalization, up to 4 weeks	WBC taken pre-op and days 1,2,3 post-op

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Sweden