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OpenTrials
Completed

NCT Number: NCT03917888

Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

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.

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tribhuvan university teaching hospital

Kathmandu, Bagmati, 44600, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung Ultrasound

Diagnostic Test

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

Primary outcomes

  1. ventilator free days

    Time frame: 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 outcomes

  1. icu mortality

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

    death during icu stay

  2. icu length of stay

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

    total duration of stay in icu

  3. delta sofa

    Time frame: 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

  4. ventilator days

    Time frame: day 28 from intubation

    total days the patient remains in mechanical ventilation

  5. antibiotic duration

    Time frame: day 14 from initiation of antibiotic

    total days the patient receives antibiotics for VAP

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2019
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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