Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

NCT03917888 | Completed

• 1 other identifier: 78611
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Keywords

ventilator associated pneumonia; lung ultrasound

Outcome Measures

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

  day 28 from diagnosis of VAP

Secondary Outcomes (5)

• icu mortality

  through study completion, an average of 3 months

• icu length of stay

  through study completion, an average of 3 months

• delta sofa

  day 4 from VAP diagnosis

• ventilator days

  day 28 from intubation

• antibiotic duration

  day 14 from initiation of antibiotic

Study Arms (2)

Lung ultrasound

EXPERIMENTAL

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

Diagnostic Test: lung ultrasound

Chest x-ray

NO INTERVENTION

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

Interventions

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

Lung ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanical ventilation for more than 48 hours
• Absence of pneumonia as the reason for mechanical ventilation (includes clinical, radiological or sonographic diagnosis)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Tribhuvan university teaching hospital

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Officials

• Saurabh Pradhan, DM

  Institute of Medicine, TUTH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DM (Critical care medicine)

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 17, 2019
• Study Start: September 10, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: access will be shared on request

Locations

NE (1)