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NeurosurgeryNCT03580993

Lung and Heart USG for Predicting Weaning in Neurosurgical Patients

An observational study of Neurosurgery and Mechanical Ventilation, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neurosurgery, Mechanical Ventilation, Extubation
What is being tested?
Lung Ultrasound
How many people
27 participants
Where
1 siteIndia
Study dates
30 Jan 2018to 15 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

India1 site
  • National Institute of Mental Heath and Neurosciences

    Bangalore, Karnataka, 560029

Other trials in India

About this study

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

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.

Read the 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.

Being tested
Lung Ultrasound
Keywords
Critical Illness, Ultrasonography
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung UltrasoundDiagnostic test

    Also called Echocardiography

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

Study groups in NCT03580993
Study groupRoleWhat they receive
SBT CompletersThose patients who successfully complete a spontaneous breathing trial of 2 hours.
Receives: Diagnostic Test: Lung Ultrasound
SBT Non-completersThose patients who fail to complete a spontaneous breathing trial of 2 hours.
Receives: Diagnostic Test: Lung Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  1. Change in Fractional Area Change over the four study time points

    Echocardiographic parameter measuring ventricular systolic function.

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

  2. Change in Deceleration time of E over the four study time points

    Echocardiographic parameter measuring ventricular diastolic function.

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

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

    Echocardiographic parameter measuring ventricular diastolic function.

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

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

    Echocardiographic parameter measuring ventricular diastolic function.

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

  5. Change in Systolic Blood Pressure over the four study time points

    Systolic Blood Pressure

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

  6. Change in Diastolic Blood Pressure over the four study time points

    Diastolic Blood Pressure

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

  7. Change in Heart Rate over the four study time points

    Heart Rate

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2018
  2. Study start30 Jan 2018
  3. Primary completion15 Jun 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580993
Sponsor's protocol ID
IEC(BS & NS DIV)/2017-18
Status last verified
Jul 2018
First submitted
22 Jun 2018
Last updated
10 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neurosurgery and Mechanical Ventilation, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lung Ultrasound Score over the four study time points (time frame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.

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