Protocol summary
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Study aim
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Investigating the effect of adding bronchoscopic suction of secretions to the routine treatment of ventilator-associated pneumonia in patients admitted to the surgical intensive care unit
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Design
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A total of 90 patients admitted to the surgical intensive care unit who are eligible for inclusion in the study will be selected by convenience sampling method. Each participant will be assigned a code and will be randomly assigned into the intervention or control group.
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Settings and conduct
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This randomized controlled, triple-blinded clinical trial will be performed on patients admitted to the surgical and traumatic intensive care unit of Imam Reza Hospital in Birjand, who are diagnosed with ventilator-associated pneumonia 48 hours after mechanical ventilation. Information about the purpose of the study is explained to them and they will be assigned randomly into intervention or control groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diagnosis of ventilator-associated pneumonia after 48 hours of mechanical ventilation and informed consent for participation in the study. Major exclusion criteria: Pregnancy; infliction with pneumonia before intubation or 48 hours before intubation; and antibiotic use before intubation.
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Intervention groups
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Control group (routine): Individuals undergo antibiotic therapy and closed suction using a 50-cc normal sterile saline on a daily basis.
Intervention group (bronchoscopic suction): Patients will undergo bronchoscopic suction every other day in addition to the treatment received by the control group.
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Main outcome variables
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Recovery based on Apache II criteria
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140519017756N45
Registration date:
2018-08-29, 1397/06/07
Registration timing:
registered_while_recruiting
Last update:
2020-01-12, 1398/10/22
Update count:
1
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Registration date
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2018-08-29, 1397/06/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-22, 1397/04/01
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Expected recruitment end date
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2019-04-20, 1398/01/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of the routine procedure and the routine procedure supplemented by bronchoscopic suctioning in treating ventilator-associated pneumonia in patients admitted to the surgical intensive care unit
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Public title
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Impact of adding bronchoscopic suction to the routine therapy of pneumonia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of ventilator-associated pneumonia after 48 hours of mechanical ventilation
Informed consent for participation in the study
Exclusion criteria:
Pregnancy
Infliction with pneumonia before intubation or 48 hours before intubation
Antibiotic use before intubation
Suffering from diseases that reduce immunity level
Use of immunosuppressant drugs
Patients with neutropenia (less than or equal to 500 neutrophils per milliliter)
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Age
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No age limit
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients who are eligible to participate will be assigned a code. Afterward, the participants will be allocated to the intervention group or the control group using the table of random numbers.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In addition to the participants themselves who are unaware of the intervention they receive, data collector and data analyzer are also both blinded to the allocated groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-09-12, 1396/06/21
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Ethics committee reference number
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IR.BUMS.REC.1396.136
Health conditions studied
1
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Description of health condition studied
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ventilator-associated pneumonia
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ICD-10 code
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J12.8
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ICD-10 code description
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Other viral pneumonia
Primary outcomes
1
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Description
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Improvement status according to APACHI II criteria
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Timepoint
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daily
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Method of measurement
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APACHI II checklist
Secondary outcomes
1
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Description
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temperature
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Timepoint
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every 3 hours daily for a maximum of 10 days
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Method of measurement
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thermometer
2
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Description
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Number of blood leukocytes
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Timepoint
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on a daily basis
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Method of measurement
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laboratory results
3
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Description
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Blood oxygenation status
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Timepoint
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on a daily basis
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Method of measurement
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arterial blood gas test
4
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Description
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tracheal aspirate culture
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Timepoint
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at baseline and on completion day of study
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Method of measurement
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laboratory results
5
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Description
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mortality
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Timepoint
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on a daily basis for 10 days
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Method of measurement
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observation
Intervention groups
1
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Description
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Control group (routine): Individuals undergo antibiotic therapy and closed suction using a 50-cc normal sterile saline on a daily basis.
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Category
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Treatment - Other
2
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Description
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Intervention group (bronchoscopic suction): Patients will undergo bronchoscopic suction every other day in addition to the treatment received by the control group.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Birjand University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Deidentified Individual Participant Data Set
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When the data will become available and for how long
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after the paper extracted from the study is published and for 6 months
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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research purposes
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From where data/document is obtainable
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email
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What processes are involved for a request to access data/document
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email to the corresponding author
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Comments
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