Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

NCT ID: NCT03917888

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-10
• Study Completion Date: 2018-08-10

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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Lung ultrasound

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

Group Type: EXPERIMENTAL

lung ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Chest x-ray

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

lung ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

Sponsor Role: lead

Responsible Party

Saurabh Pradhan

MD, DM (Critical care medicine)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saurabh Pradhan, DM

Role: PRINCIPAL_INVESTIGATOR

Institute of Medicine, TUTH

Locations

Tribhuvan university teaching hospital

Kathmandu, Bagmati, Nepal

Countries

Nepal

Other Identifiers

78611

Identifier Type: -

Identifier Source: org_study_id