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Intubation Assist Clinical Study

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ClinicalTrials.gov Identifier: NCT03301324
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

Brief Summary:
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 or disease Intervention/treatment
Intubation, Intratracheal Device: Intubation Assist Dashboard

Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intubation Assist Clinical Study
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017

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.


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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

Publications:
Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT03301324     History of Changes
Other Study ID Numbers: 7701
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
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