The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia

NCT ID: NCT04325685

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-11-07

Brief Summary

Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).

Conditions

Trauma Injury; Brain Injuries; Abdominal Sepsis; Pancreatitis; Meningitis; Encephalitis; Seizures; Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DRUG

Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation

Antiseptic (Octenisept) group

Group Type: ACTIVE_COMPARATOR

Antiseptic Solution

Intervention Type: DRUG

Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation

Bacteriophage (Sextaphag) group

Group Type: EXPERIMENTAL

Bacteriophage

Intervention Type: DRUG

Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation

Interventions

Control

Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation

Intervention Type: DRUG

Antiseptic Solution

Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation

Intervention Type: DRUG

Bacteriophage

Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation

Intervention Type: DRUG

Other Intervention Names

Saline; Octenisept; Sextaphag

Eligibility Criteria

Inclusion Criteria

• invasive mechanical ventilation beyond 48 hours

Exclusion Criteria

• hospital - acquired pneumonia
• community - acquired pneumoniae
• BMI > 35 kg/cm2
• pregnancy
• tracheostomy
• reintubation

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

Sponsors

Northern State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Vsevolod V. Kuzkov

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"

Severodvinsk, Arkhangelskaya oblast, Russia

Countries

Russia

Other Identifiers

SGDC-VAP-1

Identifier Type: -

Identifier Source: org_study_id