Intubation Assist Clinical Study

January 16, 2018 updated by: Zoll Medical Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients scheduled for elective surgery using general anesthesia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the user interface
Time Frame: Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation
Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of transthoracic impedance
Time Frame: Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation
Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zoll Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Actual)

September 20, 2017

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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