Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 2:27 PM
Study NCT ID:
NCT01521650
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2012-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia
Status:
COMPLETED
Status Verified Date:
2021-03
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:
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: