Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917888
• Other study ID #: 78611
• Status: Completed
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: August 10, 2018

Study information

• Verified date: April 2019
• Source: Tribhuvan University Teaching Hospital, Institute Of Medicine.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

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

Locations

Country	Name	City	State
Nepal	Tribhuvan university teaching hospital	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Tribhuvan University Teaching Hospital, Institute Of Medicine.

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 28 from diagnosis of VAP
Secondary	icu mortality	death during icu stay	through study completion, an average of 3 months
Secondary	icu length of stay	total duration of stay in icu	through study completion, an average of 3 months
Secondary	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	day 4 from VAP diagnosis
Secondary	ventilator days	total days the patient remains in mechanical ventilation	day 28 from intubation
Secondary	antibiotic duration	total days the patient receives antibiotics for VAP	day 14 from initiation of antibiotic