Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

Not Applicable

Completed

• Conditions: Ventilator Associated Pneumonia
• Interventions: Diagnostic Test: lung ultrasound

• Registration Number: NCT03917888
• Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

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.

Study Timeline

• Study Start: 2017-09-10
• Primary Completion: 2018-08-10
• Study Completion: 2018-08-10
• Status Verified: 2019-04
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Study First Posted: 2019-04-17
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung ultrasound	lung ultrasound	Patients will be monitored for ventilator associated pneumonia using lung ultrasound combined with clinical features

Primary Outcome Measures

Name	Time	Method
ventilator free days	day 28 from diagnosis of VAP	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

Name	Time	Method
delta sofa	day 4 from VAP diagnosis	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
antibiotic duration	day 14 from initiation of antibiotic	total days the patient receives antibiotics for VAP
icu mortality	through study completion, an average of 3 months	death during icu stay
ventilator days	day 28 from intubation	total days the patient remains in mechanical ventilation
icu length of stay	through study completion, an average of 3 months	total duration of stay in icu

Trial Locations

Locations (1)

Tribhuvan university teaching hospital; 🇳🇵 Kathmandu, Bagmati, Nepal