We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intubation Assist Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03301324
First Posted: October 4, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zoll Medical Corporation
  Purpose
The Intubation Assist Clinical Study is an observational study of adult patients scheduled for elective surgery under general anesthesia to assess the user interface, assess transthoracic impedance by the ventilation volume and assess transthoracic impedance. Monitoring will begin at the time the patient is pre-oxygenated in preparation for endotracheal intubation and will continue until 30 minutes after intubation is achieved.

Condition Intervention
Intubation, Intratracheal Device: Intubation Assist Dashboard

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intubation Assist Clinical Study

Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • Assessment of the user interface [ Time Frame: Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation ]

Secondary Outcome Measures:
  • Assessment of transthoracic impedance [ Time Frame: Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation ]

Enrollment: 66
Actual Study Start Date: September 12, 2017
Estimated Study Completion Date: November 30, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Intubation Assist Dashboard
    The ZOLL X Series Intubation Assist Dashboard feature guides the operator through a three-step auscultation process to verify the proper placement of an endotracheal tube.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients scheduled for elective surgery using general anesthesia
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Requiring intubation and assisted ventilation
  • Patient undergoing elective surgery
  • Able to give informed consent

Exclusion Criteria:

  • Skin condition that would interfere with electrodes
  • Inability/failure to intubate
  • Pregnancy
  • Surgery that prevents the application of electrodes and monitoring equipment.
  • Previous excision of complete or partial lung; congenital lung abnormalities.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301324


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Principal Investigator: Lars Wik, MD Oslo University Hospital
  More Information

Publications:
Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT03301324     History of Changes
Other Study ID Numbers: 7701
First Submitted: September 21, 2017
First Posted: October 4, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Zoll Medical Corporation:
intubation