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.
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
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:
- Taking care of the primary event
- Deciding whether to start weaning
- Assessing the readiness to wean
- Spontaneous breathing trial (SBT)
- Extubation
- 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.
- Conditions
- Neurosurgery, Mechanical Ventilation, Extubation
- 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 group | Role | What they receive |
|---|---|---|
| SBT Completers | Those patients who successfully complete a spontaneous breathing trial of 2 hours. Receives: Diagnostic Test: Lung Ultrasound | |
| SBT Non-completers | Those 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.
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.
Measured: 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
Echocardiographic parameter measuring ventricular systolic function.
Measured: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
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
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
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
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
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
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.
- First posted10 Jul 2018
- Study start30 Jan 2018
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Lung and Heart in Predicting Successful Weaning in Mechanically Ventilated Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT03580993
- Acronym / sponsor ID
- IEC(BS & NS DIV)/2017-18
- Conditions
- Neurosurgery, Mechanical Ventilation, Extubation
- Keywords
- Critical Illness, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Taking care of the primary event
- Deciding whether to start weaning
- Assessing the readiness to wean
- Spontaneous breathing trial (SBT)
- Extubation
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBT Completers | – | Diagnostic Test: Lung UltrasoundThose patients who successfully complete a spontaneous breathing trial of 2 hours. |
| SBT Non-completers | – | Diagnostic Test: Lung UltrasoundThose patients who fail to complete a spontaneous breathing trial of 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurosurgical patients being mechanically ventilated in ICU, being weaned off mechanical ventilation.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung UltrasoundAlso: EchocardiographyLung ultrasound and Echocardiography used to derive parameters for prediction of successful SBT. | Diagnostic test | SBT Completers, SBT Non-completers |
Primary outcome
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
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.
7 secondary outcomes
Change in Fractional Area Change over the four study time points
Time frame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Change in Deceleration time of E over the four study time points
Time frame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Change in E:A Ratio over the four study time points
Time frame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Change in E:E' Ratio over the four study time points
Time frame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Change in Systolic Blood Pressure over the four study time points
Time frame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Change in Diastolic Blood Pressure over the four study time points
Time frame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Change in Heart Rate over the four study time points
Time frame: Pre-SBT, Half hour during SBT, 2 hours during SBT, Pre-Extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.