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OpenTrials
Completed

NCT Number: NCT03113799

A Study Evaluate Aqueduct's Smart External Drain

To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically:

* Number, type and duration of staff interactions. * Regulating and controlling ICP and CSF drainage. * Maintaining system control with patient movement.

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Key information

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital, Seattle, Washington, United States

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About this study

In this two day clinical trial, subjects will be observed on Day 1 of study during their routine treatment and using their already existing EVD. On Day 2 of study; subjects will be switched to the Smart External Drain for monitoring and management of ICP and CSF

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment.
  • GCS > 13 (minimum of E3V5M5) prior to study treatment.
  • Subject must be scheduled to have an EVD placed as part of routine management and for a length of at least 48 hours. (e.g. in the setting of a tumor removal or treatment of hydrocephalus)
  • Age 5-80.
  • Stable Vital Signs - Blood pressure (Systolic and Diastolic), Heart Rate, Respiratory Rate and weight assessed as not clinically significant (NCS) and afebrile as per PI/Sub-assessment. (Stable Vital signs will be re-assessed again prior to treatment with the SED on Day 2)
  • Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)
  • Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.
  • Able to stand
  • Able to obtain consent

Exclusion criteria

  • Refractory ICP or needing active ICP management
  • Unable to tolerate brief clamping of EVD (<5min)
  • Unable to follow simple commands
  • Unconscious
  • Anticoagulant Therapy
  • Known bleeding diathesis
  • Scalp Infection
  • In the opinion of the Investigator the subject is not a good study candidate

Treatment and study plan

Smart External Drain - SED

Device

Subject will be treated on Day 2 with the SED. ICP and CSF volumes will be recorded at prespecified intervals while subject is stationary and while subject is engaged in protocol-driven directed movements.

Primary outcomes

  1. Staff interactions

    Time frame: Two Days

    Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)

Secondary outcomes

  1. Staff Time

    Time frame: Two Days

    Total minutes spent by staff interacting with standard EVD compared to SED

  2. Safety

    Time frame: Two Days

    Number of Participants with Adverse Events That Are Related to Treatment

Sponsors and collaborators

Lead sponsor

Aqueduct Critical Care

Industry

Registry information

Official study title

A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains

Acronym: SED

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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