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Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of Ventilator Associated Pneumonia: a Diagnostic Randomized Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03917888
Enrollment
88
Registered
2019-04-17
Start date
2017-09-10
Completion date
2018-08-10
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

ventilator associated pneumonia, lung ultrasound

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.

Interventions

DIAGNOSTIC_TESTlung ultrasound

lung ultrasound will be performed daily in mechanically ventilated patients after 48 hours of ventilation to screen for ventilator associated pneumonia

Sponsors

Tribhuvan University Teaching Hospital, Institute Of Medicine.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ventilator free daysday 28 from diagnosis of VAPnumber 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

MeasureTime frameDescription
icu mortalitythrough study completion, an average of 3 monthsdeath during icu stay
icu length of staythrough study completion, an average of 3 monthstotal duration of stay in icu
delta sofaday 4 from VAP diagnosischange 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 daysday 28 from intubationtotal days the patient remains in mechanical ventilation
antibiotic durationday 14 from initiation of antibiotictotal days the patient receives antibiotics for VAP

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026