Lung and Heart USG for Predicting Weaning in Neurosurgical Patients

Mechanical Ventilation Clinical Trial

Official title:

Ultrasonographic Evaluation of Lung and Heart in Predicting Successful Weaning in Mechanically Ventilated Neurosurgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580993
• Other study ID #: IEC(BS & NS DIV)/2017-18
• Status: Completed
• Start date: January 30, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: July 2018
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Ultrasonography has become a ubiquitous feature of Intensive care nowadays, with its influence ranging from various diagnostics to various therapeutic interventions. It is readily available at the bedside and is non-invasive, making it an ideal tool in the hands of the intensivist. It has excellent safety profile, and hence can be performed repeatedly. These days it has become an indispensable tool in the intensive care units owing to its potential utility in the process of weaning a critically ill patient from mechanical ventilator support.

A neurosurgical patient is different from any other post-operative or critically ill patients. Their altered cerebral physiology, specific goals of therapy, varied response to usual management protocols, put them in a different league whole together. The primary aim of care for these patients is to detect and prevent any secondary neurological insult while supporting systemic and neurological homeostasis. Hypoxia and hypercarbia are factors which need to be absolutely avoided while caring for such patients. A good proportion of these patients will have respiratory instability, airway compromise and altered sensorium, which makes them prone to hypoxia and hypercarbia. To avoid these secondary insults to the neurological system, endotracheal intubation and mechanical ventilation is instituted in patients who are at high risk. Mechanical ventilation is continued until the patient is clinically stabilized and primary neurological damage has been taken care of. Subsequently the transition from control ventilation to spontaneous ventilation begins

The weaning process from mechanical ventilation involves sequential reduction of ventilatory parameters, assessment of readiness of the patient for extubation and when all these criterias are acceptable, then finally extubation. Daily, meticulous evaluation of clinical and neurological conditions and completion of spontaneous breathing trial (SBT) should be considered in order to recognize and facilitate the process of withdrawal of the mechanical ventilation. Extubation is considered as a success when the ventilator prosthesis is removed after the patient passed the SBT and there is no need for reinstitution of the MV in the next 48 hours. The entire process of weaning can be categorised as a six step process:

1. Taking care of the primary event

2. Deciding whether to start weaning

3. Assessing the readiness to wean

4. Spontaneous breathing trial (SBT)

5. Extubation

6. Assessment of probable reintubation6

Several parameters have been instituted for assessing the capability of weaning. These include: Rapid Shallow Breathing Index, which is the ratio of respiratory frequency to tidal volume (RSBI=f/VT), Pulmonary gas exchange (like: PaO2/FiO2, PaCO2), Vital Capacity (VC), Minute Ventilation and Static Compliance. Weaning may not always have a successful outcome. Difficult weaning may in fact be due to different or mixed etiologies, the diagnosis of which requires meticulous monitoring of various physiologic and objective parameters. Assessment of lung aeration by ultrasonography is rapidly gaining significance in weaning protocol. Apart from lung ultrasonography, the role of transthoracic echocardiography in successfully predicting weaning capability have been investigated in the recent times. Cardiac related weaning failure may be due to systolic LV dysfunction or isolated diastolic dysfunction. By this study we are trying to evaluate the scope of ultrasonography in detection of lung aeration and cardiac systolic and diastolic function in mechanically ventilated neurosurgical patients undergoing weaning; and whether they can be used as a good diagnostic tool to detect those who are likely to fail weaning in this specific subset of patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All neurosurgical patients mechanically ventilated for more than 48 hrs and planned for weaning.

2. All patients whose underlying disease that required intubation was considered reversed or stabilised by the attending physician, rendering them eligible for spontaneous breathing trials.

Exclusion Criteria:

1. Uncooperative patient or the absence of a proper ultrasonographic window

2. Pregnancy

3. Patients having a GCS score of less than 8

4. Those having a pre weaning PaO2/ FiO2 ratio of less than 200

5. Severe ICU acquired neuromyopathy

6. Patients with lower cranial nerve involvement

7. Tracheostomised patients

8. Patients having high spinal cord lesions (above T8)

9. Presence of thoracostomy, pneumothorax or pneumomediastinum

10. Presence of rib fractures

11. Presence of pleural effusion

12. Patients having severe left ventricular dysfunction (LVEF < 35%)

13. Patients with planned prophylactic noninvasive ventilation

Related Conditions & MeSH terms

• Extubation
• Mechanical Ventilation
• Neurosurgery

Intervention

Diagnostic Test:
• Lung Ultrasound
Lung ultrasound and Echocardiography used to derive parameters for prediction of successful SBT.

Locations

Country	Name	City	State
India	National Institute of Mental Heath and Neurosciences	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Normal aeration; Moderate loss of lung aeration; Severe loss of lung aeration; 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	Change in Fractional Area Change over the four study time points	Echocardiographic parameter measuring ventricular systolic function.	Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Secondary	Change in Deceleration time of E over the four study time points	Echocardiographic parameter measuring ventricular diastolic function.	Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Secondary	Change in E:A Ratio over the four study time points	Echocardiographic parameter measuring ventricular diastolic function.	Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Secondary	Change in E:E' Ratio over the four study time points	Echocardiographic parameter measuring ventricular diastolic function.	Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Secondary	Change in Systolic Blood Pressure over the four study time points	Systolic Blood Pressure	Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Secondary	Change in Diastolic Blood Pressure over the four study time points	Diastolic Blood Pressure	Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Secondary	Change in Heart Rate over the four study time points	Heart Rate	Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation