Lung and Heart USG for Predicting Weaning in Neurosurgical Patients

NCT03580993 | Completed

• 1 other identifier: IEC(BS & NS DIV)/2017-18
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasonography is a commonly used diagnostic and procedural adjunctive modality in intensive care. Weaning of neurosurgical patients off ventilatory support is a critical procedure, fraught with risks of hypoxia and hypercapnia. Weaning involves sequential reduction of ventilatory support and regular assessments for extubation followed by spontaneous breathing trials. In this study, we evaluate parameters of ultrasonographic evaluation of lung aeration and cardiac function in neurosurgical patients undergoing weaning and their ability to predict successful weaning and extubation.

Conditions

Neurosurgery; Mechanical Ventilation; Extubation

Keywords

Critical Illness; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Change in Lung Ultrasound Score over the four study time points

  Each intercostal space of upper and lower parts of the anterior, lateral, and posterior regions of the left and right chest wall are carefully examined for four lung aeration patterns: 1. Normal aeration 2. Moderate loss of lung aeration 3. Severe loss of lung aeration 4. Lung consolidation For a given region of interest, points are allocated according to the worst ultrasound pattern observed: N = 0, B1 lines = 1, B2 lines = 2, C = 3. The LUS score ranging between 0 and 36 will be calculated as the sum of points.

  Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation

Secondary Outcomes (7)

• Change in Fractional Area Change over the four study time points

  Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation

• Change in Deceleration time of E over the four study time points

  Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation

• Change in E:A Ratio over the four study time points

  Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation

• Change in E:E' Ratio over the four study time points

  Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation

• Change in Systolic Blood Pressure over the four study time points

  Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation

Study Arms (2)

SBT Completers

Those patients who successfully complete a spontaneous breathing trial of 2 hours.

Diagnostic Test: Lung Ultrasound

SBT Non-completers

Those patients who fail to complete a spontaneous breathing trial of 2 hours.

Diagnostic Test: Lung Ultrasound

Interventions

Lung Ultrasound DIAGNOSTIC_TEST

Lung ultrasound and Echocardiography used to derive parameters for prediction of successful SBT.

Also known as: Echocardiography

SBT Completers; SBT Non-completers

Eligibility Criteria

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

Study Population

Neurosurgical patients being mechanically ventilated in ICU, being weaned off mechanical ventilation.

You may qualify if:

• All neurosurgical patients mechanically ventilated for more than 48 hrs and planned for weaning.
• All patients whose underlying disease that required intubation was considered reversed or stabilised by the attending physician, rendering them eligible for spontaneous breathing trials.

You may not qualify if:

• Uncooperative patient or the absence of a proper ultrasonographic window
• Pregnancy
• Patients having a GCS score of less than 8
• Those having a pre weaning PaO2/ FiO2 ratio of less than 200
• Severe ICU acquired neuromyopathy
• Patients with lower cranial nerve involvement
• Tracheostomised patients
• Patients having high spinal cord lesions (above T8)
• Presence of thoracostomy, pneumothorax or pneumomediastinum
• Presence of rib fractures
• Presence of pleural effusion
• Patients having severe left ventricular dysfunction (LVEF \< 35%)
• Patients with planned prophylactic noninvasive ventilation

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

Study Sites (1)

National Institute of Mental Heath and Neurosciences

Bangalore, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 10, 2018
• Study Start: January 30, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)