Changes in Optic Nerve Sheath Diameter in Response to Various Levels of End Tidal Carbon Dioxide Levels

NCT02711774 | Completed DMC

• 1 other identifier: IEC-128/05.02,2016, RP-34/2016
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brachial Plexus Injury

Outcome Measures

Primary Outcomes (1)

• 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

  4 months

Interventions

ultrasonography DEVICE

ONSD will be measured by a 6-13 MHz linear probe of the ultrasound machine.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with a history of head injury, any respiratory or cardiovascular system disease or non consenting patients.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Indu Kapoor

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Indu Kapoor

  AIIMS, New Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 17, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 17, 2016

Record last verified: 2016-11

Locations

IN (1)