CClinicalTrials.gg
CompletedNCT03917888Updated Apr 17, 2019

Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

An interventional study of lung ultrasound in Ventilator Associated Pneumonia, sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine.. Completed at 1 site in Nepal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine. · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Sep 2017, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventilator Associated Pneumonia

Keywords

  • ventilator associated pneumonia
  • lung ultrasound
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 88 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine. is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Lung ultrasound

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

    Diagnostic Test: lung ultrasound

  • No intervention
    Chest x-ray

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

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: day 28 from diagnosis of VAP

Secondary outcomes

  1. icu mortality

    death during icu stay

    Time frame: through study completion, an average of 3 months

  2. icu length of stay

    total duration of stay in icu

    Time frame: through study completion, an average of 3 months

  3. 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

    Time frame: day 4 from VAP diagnosis

  4. ventilator days

    total days the patient remains in mechanical ventilation

    Time frame: day 28 from intubation

  5. antibiotic duration

    total days the patient receives antibiotics for VAP

    Time frame: day 14 from initiation of antibiotic

07

Study locations

1 site
  • Tribhuvan university teaching hospital
    Kathmandu, Bagmati 44600, Nepal
08

References and documents

Individual participant data

Plan to share: Yes — all data

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03917888
Lead sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Responsible party
Saurabh Pradhan (MD, DM (Critical care medicine), Tribhuvan University Teaching Hospital, Institute Of Medicine.) — Principal investigator
First posted
Apr 17, 2019
Start date
Sep 10, 2017
Primary completion
Aug 10, 2018
Completion
Aug 10, 2018
Last update
Apr 17, 2019

Study contacts

Saurabh Pradhan, DM
principal investigator · Institute of Medicine, TUTH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion