Clinical trial NCT03580993: Lung and Heart USG for Predicting Weaning in Neurosurgical Patients
Official title: Ultrasonographic Evaluation of Lung and Heart in Predicting Successful Weaning in Mechanically Ventilated Neurosurgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurosurgery
Mechanical Ventilation
Extubation
Keywords: Critical Illness
Ultrasonography
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurosurgical patients being mechanically ventilated in ICU, being weaned off mechanical ventilation.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Lung Ultrasound Score over the four study time points
timeFrame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Secondary outcomes:
measure: Change in Fractional Area Change over the four study time points
timeFrame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
measure: Change in Deceleration time of E over the four study time points
timeFrame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
measure: Change in E:A Ratio over the four study time points
timeFrame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
measure: Change in E:E' Ratio over the four study time points
timeFrame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
measure: Change in Systolic Blood Pressure over the four study time points
timeFrame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
measure: Change in Diastolic Blood Pressure over the four study time points
timeFrame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
measure: Change in Heart Rate over the four study time points
timeFrame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Other outcomes:
Locations:
city: Bangalore
country: India
facility: National Institute of Mental Heath and Neurosciences
state: Karnataka
Study officials:
References: