Brachial Plexus InjuryNCT02711774
Changes in Optic Nerve Sheath Diameter in Response to Various Levels of End Tidal Carbon Dioxide Levels
An observational study of Brachial Plexus Injury, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Intracranial Pressure ( ICP ) monitoring is an essential component of traumatic brain injured ( TBI ) patients management. The clinical signs of raised ICP may be unreliable and may reflect relatively late cerebral decompensation. ICP may be monitored by invasive or non invasive techniques. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Injury
- What is being tested?
- ultrasonography
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2016to Nov 2016
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All ASA grade I adult patients in non head injury category between 18 to 65 years, of either gender undergoing brachial plexus injury surgery under general anesthesia.
Who may be able to join
- ASA grade I adult patients in non head injury category between 18 to 65 years, of either gender undergoing brachial plexus injury surgery under general anesthesia.
Who cannot join
- Patients with a history of head injury, any respiratory or cardiovascular system disease or non consenting patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Optic Nerve Sheath Diameter in Response to Various Levels of End Tidal Carbon Dioxide Levels in Healthy Patients Under General Anaesthesia
Intracranial Pressure ( ICP ) monitoring is an essential component of traumatic brain injured ( TBI ) patients management. The clinical signs of raised ICP may be unreliable and may reflect relatively late cerebral decompensation. ICP may be monitored by invasive or non invasive techniques. While invasive techniques show the real time values of ICP, they are associated with many complications like, intracranial bleeding and infection, occlusion of the catheter tip by blood, debris and difficult to locate ventricle in presence of cerebral oedema. All these drawbacks of invasive methods can be averted by employing non invasive techniques of ICP monitoring. Although they do not show a real time value but are excellent tools to detect presence or absence of raised ICP. Elevated ICP can be detected by Computarised tomographic scan (CT) or Magnetic resonance imaging (MRI) but , these techniques are time consuming and require transportation of a patients who may be unstable .The quick and non invasive nature of ultrasonography is fast becoming popular for rapid detection of elevated ICP at bedside in emergency and ICU by monitoring the optic nerve sheath diameter ( ONSD ). Its limitations notwithstanding, ultrasonographic ONSD monitoring is likely to be more reliable than clinical assessment in the diagnosis of intracranial hypertension especially, when patient is under sedation which precludes proper clinical examination. Therefore, in recent years ,among non invasive methods, bedside ocular ultrasonography to monitor ICP has gained popularity.
Carbon dioxide being a potent modulator of cerebral vascular tone, alters the ICP by changing the size of cerebral vasculature and thereby, cerebral blood flow (CBF) and this action occurs very rapidly, over e period of few minutes. In a range of PaCO2 20mmHg to 80 mmHg the cerebral blood flow changes in a linear manner. End tidal carbon dioxide concentration(EtCO2) is a surrogate measure of PaCO2 (especially in a haemodyanimically stable patient with healthy lungs ) and is routinely monitored continuously in patients subjected to general anaesthesia. To date there is very little literature on the effects changing EtCO2 on ONSD . This prompted us to conduct this study to find out the effects of different levels of EtCO2 on ONSD.
Read the detailed description
In this study we monitored the effect of three different EtCO2 levels ( 40mmHg,30mmHg and 50mmHg ). In these healthy patients we observed rapid response in ONSD with changes in EtCO2. This again highlights the fact that optic nerve being in direct communication with the brain ,the pressure changes in the latter are reflected in the ONSD. The alteration in ONSD was immediate in response to EtCO2 changes, and moreover,changes in ONSD were parallel to the EtCO2 changes. Since CBF and cerebral blood volume change in response to changes in PaCO2, the ONSD also changes accordingly. Over the years ,advancements in monitoring of ICP has enabled the diagnosis of elevated ICP reliably by non-invasive techniques.Optic nerve sheath diameter measurement using bedside ultrasound has been shown to correlate with clinical and radiologic signs and symptoms of raised ICP. Despite the association between ONSD and PaCO2 , there is scanty literature on ONSD responsiveness to a more dynamic surrogate of PaCO2, that is EtCO2. The pertinent advantages of EtCO2 over PaCO2 measurement is that the former is continuously monitored under anesthesia and avoids time consuming process of arterial blood gas sampling. Moreover, the sensitivity of ICP to even small fluctuations in EtCO2 has been reported in literature. Animal studies have estimated that the rate of this increase in ONSD by 0.0034mm/mmHg increase in ICP.
The ONSD was smallest (0.29cm) at EtCO2 30mmHg, and biggest (0.40cm ) at EtCO2 50mmHg while it was intermediate ( 0.34cm) at EtCO2 40 mmHg. These changes in ONSD are direct representation of changes in ICP brought about by changes in CBF due to PaCO2 changes. Based on results of Bland Altman plots, the calculated 95% confidence interval (CI) for the difference of two measures( EtCO2 40mmHg and 30mmHg ) on ONSD was 0. 009 to 0.102 and the calculated CI for the difference of other two measures ( EtCO2 40mmHg and 50mmHg ) on ONSD was 0.152 to 0. 29 and thus were observed to be statistically insignificant.
Recently Kim et al studied ONSD responsiveness to two levels of EtCO2 ,40 and 50mmHg, each measured at 1 and 5min and they observed significant changes in the diameter of ONSD. Thus their results are at variance with our study. Various possibly reasons for differences in findings are Kim et al studied a small number of patients as opposed to a relatively larger sample size in our study. Also they used total intravenous anesthesia combining propofol and remifentanil infusion. This combination is more likely to predispose patients to systemic hypotension which in turn would increase ICP by causing cerebral vasodilation. Other possibility for different results may be that sonographic measurements of ONSD may vary by the observer's skills or even type of ultrasound device.
According to available literature, the upper limit of ONSD used to define ICP more than 20mmHg (raised ICP ) ranges from 0.48 to 0.57 cm. In our study ,the upper limit of ONSD at EtCO2 level 50mmHg was average of 0.40cm which implies that even at EtCO2 50mmHg, intracranial hypertension is a remote possibility in healthy non-neurosurgical patients with normal brain compliance. We kept constant the factors such as position of patients, time of measurement after achieving target EtCO2, measuring ONSD in a single plain ( transverse) and involving same experienced operator,,thereby, avoiding any confounding factors.
- Conditions
- Brachial Plexus Injury
- Being tested
- ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
ONSD will be measured by a 6-13 MHz linear probe of the ultrasound machine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optic nerve sheath diameter [ONSD] measured by ultrasonography in response to change in End tidal Co2 concentration in patients with brachial plexus injury
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus InjuryStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indu Kapoor, All India Institute of Medical Sciences
- Investigators
- Indu Kapoor, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711774
- Sponsor's protocol ID
- IEC-128/05.02,2016, RP-34/2016
- Status last verified
- Nov 2016
- First submitted
- 9 Mar 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Optic Nerve Sheath Diameter in Response to Various Levels of End Tidal Carbon Dioxide Levels in Healthy Patients Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT02711774
- Acronym / sponsor ID
- IEC-128/05.02,2016, RP-34/2016
- Conditions
- Brachial Plexus Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Mar 2016 (estimated)
- 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.
Intracranial Pressure ( ICP ) monitoring is an essential component of traumatic brain injured ( TBI ) patients management. The clinical signs of raised ICP may be unreliable and may reflect relatively late cerebral decompensation. ICP may be monitored by invasive or non invasive techniques. While invasive techniques show the real time values of ICP, they are associated with many complications like, intracranial bleeding and infection, occlusion of the catheter tip by blood, debris and difficult to locate ventricle in presence of cerebral oedema. All these drawbacks of invasive methods can be averted by employing non invasive techniques of ICP monitoring. Although they do not show a real time value but are excellent tools to detect presence or absence of raised ICP. Elevated ICP can be detected by Computarised tomographic scan (CT) or Magnetic resonance imaging (MRI) but , these techniques are time consuming and require transportation of a patients who may be unstable .The quick and non invasive nature of ultrasonography is fast becoming popular for rapid detection of elevated ICP at bedside in emergency and ICU by monitoring the optic nerve sheath diameter ( ONSD ). Its limitations notwithstanding, ultrasonographic ONSD monitoring is likely to be more reliable than clinical assessment in the diagnosis of intracranial hypertension especially, when patient is under sedation which precludes proper clinical examination. Therefore, in recent years ,among non invasive methods, bedside ocular ultrasonography to monitor ICP has gained popularity.
Carbon dioxide being a potent modulator of cerebral vascular tone, alters the ICP by changing the size of cerebral vasculature and thereby, cerebral blood flow (CBF) and this action occurs very rapidly, over e period of few minutes. In a range of PaCO2 20mmHg to 80 mmHg the cerebral blood flow changes in a linear manner. End tidal carbon dioxide concentration(EtCO2) is a surrogate measure of PaCO2 (especially in a haemodyanimically stable patient with healthy lungs ) and is routinely monitored continuously in patients subjected to general anaesthesia. To date there is very little literature on the effects changing EtCO2 on ONSD . This prompted us to conduct this study to find out the effects of different levels of EtCO2 on ONSD.
Detailed description
In this study we monitored the effect of three different EtCO2 levels ( 40mmHg,30mmHg and 50mmHg ). In these healthy patients we observed rapid response in ONSD with changes in EtCO2. This again highlights the fact that optic nerve being in direct communication with the brain ,the pressure changes in the latter are reflected in the ONSD. The alteration in ONSD was immediate in response to EtCO2 changes, and moreover,changes in ONSD were parallel to the EtCO2 changes. Since CBF and cerebral blood volume change in response to changes in PaCO2, the ONSD also changes accordingly. Over the years ,advancements in monitoring of ICP has enabled the diagnosis of elevated ICP reliably by non-invasive techniques.Optic nerve sheath diameter measurement using bedside ultrasound has been shown to correlate with clinical and radiologic signs and symptoms of raised ICP. Despite the association between ONSD and PaCO2 , there is scanty literature on ONSD responsiveness to a more dynamic surrogate of PaCO2, that is EtCO2. The pertinent advantages of EtCO2 over PaCO2 measurement is that the former is continuously monitored under anesthesia and avoids time consuming process of arterial blood gas sampling. Moreover, the sensitivity of ICP to even small fluctuations in EtCO2 has been reported in literature. Animal studies have estimated that the rate of this increase in ONSD by 0.0034mm/mmHg increase in ICP.
The ONSD was smallest (0.29cm) at EtCO2 30mmHg, and biggest (0.40cm ) at EtCO2 50mmHg while it was intermediate ( 0.34cm) at EtCO2 40 mmHg. These changes in ONSD are direct representation of changes in ICP brought about by changes in CBF due to PaCO2 changes. Based on results of Bland Altman plots, the calculated 95% confidence interval (CI) for the difference of two measures( EtCO2 40mmHg and 30mmHg ) on ONSD was 0. 009 to 0.102 and the calculated CI for the difference of other two measures ( EtCO2 40mmHg and 50mmHg ) on ONSD was 0.152 to 0. 29 and thus were observed to be statistically insignificant.
Recently Kim et al studied ONSD responsiveness to two levels of EtCO2 ,40 and 50mmHg, each measured at 1 and 5min and they observed significant changes in the diameter of ONSD. Thus their results are at variance with our study. Various possibly reasons for differences in findings are Kim et al studied a small number of patients as opposed to a relatively larger sample size in our study. Also they used total intravenous anesthesia combining propofol and remifentanil infusion. This combination is more likely to predispose patients to systemic hypotension which in turn would increase ICP by causing cerebral vasodilation. Other possibility for different results may be that sonographic measurements of ONSD may vary by the observer's skills or even type of ultrasound device.
According to available literature, the upper limit of ONSD used to define ICP more than 20mmHg (raised ICP ) ranges from 0.48 to 0.57 cm. In our study ,the upper limit of ONSD at EtCO2 level 50mmHg was average of 0.40cm which implies that even at EtCO2 50mmHg, intracranial hypertension is a remote possibility in healthy non-neurosurgical patients with normal brain compliance. We kept constant the factors such as position of patients, time of measurement after achieving target EtCO2, measuring ONSD in a single plain ( transverse) and involving same experienced operator,,thereby, avoiding any confounding factors.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All ASA grade I adult patients in non head injury category between 18 to 65 years, of either gender undergoing brachial plexus injury surgery under general anesthesia.
Key inclusion criteria (1 listed)
- ASA grade I adult patients in non head injury category between 18 to 65 years, of either gender undergoing brachial plexus injury surgery under general anesthesia.
Key exclusion criteria (1 listed)
- Patients with a history of head injury, any respiratory or cardiovascular system disease or non consenting patients.
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 |
|---|---|---|
| ultrasonographyONSD will be measured by a 6-13 MHz linear probe of the ultrasound machine. | Device | – |
Primary outcome
Change in Optic nerve sheath diameter [ONSD] measured by ultrasonography in response to change in End tidal Co2 concentration in patients with brachial plexus injury
Time frame: 4 months
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 17 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Indu Kapoor principal investigator
All India Institute of Medical Sciences
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 Brachial Plexus Injury, run by All India Institute of Medical Sciences 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 1 inclusion and 1 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 17 Nov 2016. 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 Optic nerve sheath diameter [ONSD] measured by ultrasonography in response to change in End tidal Co2 concentration in patients with brachial plexus injury (time frame: 4 months). 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 17 Nov 2016.