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Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

Primary Purpose

Ventilator Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
lung ultrasound
Sponsored by
Tribhuvan University Teaching Hospital, Institute Of Medicine.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ventilator Associated Pneumonia focused on measuring ventilator associated pneumonia, lung ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mechanical ventilation for more than 48 hours
  • Absence of pneumonia as the reason for mechanical ventilation (includes clinical, radiological or sonographic diagnosis)

Exclusion Criteria:

  • Recent trauma or surgery to the thorax (including chest tube insertion)
  • Presence of dressings or skin conditions restricting access to the thorax
  • Confirmed pregnancy
  • If already enrolled in the study
  • Denial of consent

Sites / Locations

  • Tribhuvan university teaching hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lung ultrasound

Chest x-ray

Arm Description

Patients will be monitored for ventilator associated pneumonia using lung ultrasound combined with clinical features

Patients will be monitored for ventilator associated pneumonia using chest x-ray and clinical features.

Outcomes

Primary Outcome Measures

ventilator free days
number of days alive from day 1 (of VAP) to day 28 on which a patient breathes without assistance, if the period of unassisted breathing lasted at least 48 consecutive hours. If death occurs within 28 days then ventilator free days is counted as 0

Secondary Outcome Measures

icu mortality
death during icu stay
icu length of stay
total duration of stay in icu
delta sofa
change in Sequential Organ Failure Score (SOFA) at day 4 of onset of VAP from the day of onset of VAP. SOFA ranges from 0 to 24. Delta sofa is the difference between SOFA score at day 4 from day 0 of VAP diagnosis. the higher the difference, the better the outcome
ventilator days
total days the patient remains in mechanical ventilation
antibiotic duration
total days the patient receives antibiotics for VAP

Full Information

First Posted
April 10, 2019
Last Updated
April 15, 2019
Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
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1. Study Identification

Unique Protocol Identification Number
NCT03917888
Brief Title
Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP
Official Title
Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of Ventilator Associated Pneumonia: a Diagnostic Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study evaluates whether lung ultrasound monitoring could lead to earlier detection of ventilator associated pneumonia and influence outcome. Half of the participants will be diagnosed with VAP using a combination of lung ultrasound and clinical features and half will be diagnosed using the Johanson criteria, which is a combination of clinical features and chest x-ray.
Detailed Description
The current guidelines recommend the use of chest x-ray or computed tomography of the chest to aid in the diagnosis of VAP. However many studies have shown that chest x-ray is neither very sensitive nor specific for pneumonia, and computed tomography, though has the highest diagnostic accuracy, is not routinely performed due to logistics, safety concerns, economics and radiation exposure. Emerging studies including meta-analyses have shown high sensitivity and specificity of lung ultrasound in diagnosing pneumonia. When combined with clinical and microbiological features it has shown to be helpful in early diagnosis of VAP, but a study to show whether such early detection improves outcome is lacking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
ventilator associated pneumonia, lung ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung ultrasound
Arm Type
Experimental
Arm Description
Patients will be monitored for ventilator associated pneumonia using lung ultrasound combined with clinical features
Arm Title
Chest x-ray
Arm Type
No Intervention
Arm Description
Patients will be monitored for ventilator associated pneumonia using chest x-ray and clinical features.
Intervention Type
Diagnostic Test
Intervention Name(s)
lung ultrasound
Intervention Description
lung ultrasound will be performed daily in mechanically ventilated patients after 48 hours of ventilation to screen for ventilator associated pneumonia
Primary Outcome Measure Information:
Title
ventilator free days
Description
number of days alive from day 1 (of VAP) to day 28 on which a patient breathes without assistance, if the period of unassisted breathing lasted at least 48 consecutive hours. If death occurs within 28 days then ventilator free days is counted as 0
Time Frame
day 28 from diagnosis of VAP
Secondary Outcome Measure Information:
Title
icu mortality
Description
death during icu stay
Time Frame
through study completion, an average of 3 months
Title
icu length of stay
Description
total duration of stay in icu
Time Frame
through study completion, an average of 3 months
Title
delta sofa
Description
change in Sequential Organ Failure Score (SOFA) at day 4 of onset of VAP from the day of onset of VAP. SOFA ranges from 0 to 24. Delta sofa is the difference between SOFA score at day 4 from day 0 of VAP diagnosis. the higher the difference, the better the outcome
Time Frame
day 4 from VAP diagnosis
Title
ventilator days
Description
total days the patient remains in mechanical ventilation
Time Frame
day 28 from intubation
Title
antibiotic duration
Description
total days the patient receives antibiotics for VAP
Time Frame
day 14 from initiation of antibiotic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mechanical ventilation for more than 48 hours Absence of pneumonia as the reason for mechanical ventilation (includes clinical, radiological or sonographic diagnosis) Exclusion Criteria: Recent trauma or surgery to the thorax (including chest tube insertion) Presence of dressings or skin conditions restricting access to the thorax Confirmed pregnancy If already enrolled in the study Denial of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saurabh Pradhan, DM
Organizational Affiliation
Institute of Medicine, TUTH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tribhuvan university teaching hospital
City
Kathmandu
State/Province
Bagmati
ZIP/Postal Code
44600
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all data
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
access will be shared on request

Learn more about this trial

Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

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