Comparing iView Video Laryngoscope in the Emergency Department

March 1, 2022 updated by: Steven Schauer, Brooke Army Medical Center

A Prospective Comparison of the Disposable I-view Versus the Durable Video Laryngoscopes in the Emergency Department

The US Military is rapidly transitioning into preparing for multi-domain operations. Previous data demonstrates that the most common airway replaced in the prehospital combat setting is endotracheal intubation. Previous studies have suggested that video laryngoscopy (VL) is superior to direct laryngoscopy (DL), which is most prominently noted in the office users . However, the current durable equipment video laryngoscopes are very expensive and cost prohibitive for dispersion around the battlefield. The i-view is a novel video laryngoscope that is marketed for VL and is inexpensive and disposable. Both the durable VL and the i-view are already in use in our emergency department (ED). The investigators are also already collecting data using these devices as part of an approved protocol for an airway registry. The investigators are seeking to utilizing a clinical rotating protocol to compare these two devices in the emergency department.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE:

The investigators are seeking to implement a clinical rotating protocol in which the investigators will use alternating months for which VL device is to be used comparing the i-view to the reusable devices within our department.

The investigators are seeking to answer the following questions:

  1. Does the i-view have similar first pass success rates compared to the reusable VL devices (e.g. GlideScope, C-Mac)?
  2. Does the i-view have similar attempts required for placement compared to the reusable VL devices?

SUBJECT POPULATION:

The investigators are seeking all patients undergoing intubation for which the clinician chooses to use VL.

NUMBER OF STUDY RECORDS:

The investigators are seeking all encounters for which a VL intubation happens over the course of one years. Our limit will be based on the number of times the procedure occurs.

INCLUSION CRITERIA:

The investigators are seeking any encounter for which the patient undergoes VL intubation as part of routine clinical care.

SAMPLE SIZE ESTIMATION:

A power analysis in SAS version 9.4 (SAS Institute, Cary, NC) indicated that a total sample of 122 would be needed to find that the i-view is non-inferior to the reusable VL if the expected outcome rate (proportion of patients experiencing first-pass success) for the i-view is 87%, the expected outcome rate for the reusable VL is 92%, the noninferiority margin is 5%, power is 80%, and alpha is 5%.

DATA ANALYSIS:

The investigators will use the farrington-Manning score test for non-inferiority to test the first two hypotheses (that the i-view has a non-inferior proportion of patients experiencing hypoxic events, and that the i-view has a non-inferior first-pass success rate compared to the reusable VL devices). The farrington-Manning score test computes the proportion (risk) difference and 90% confidence interval (for a one-sided test) with regards to a predetermined non-inferiority limit. The investigators will use pairwise deletion to handle missing data points (i.e., will only exclude observations if missing data relevant to the specific analysis). Moreover, the investigators may perform regression modeling to adjust for confounders. The investigators performed all statistical analysis using Microsoft Excel (version 10, Redmond, Washington) and JMP Statistical Discovery from SAS (version 13, Cary, NC) or another available commercial software package. The investigators will present continuous variables as means and 95% confidence intervals, non-parametric continuous variables and ordinal variables as medians and interquartile ranges, and nominal variables as percentages and numbers. Significance will be set at p=0.05. The investigators will compare binomial variables using the Chi-square test, normally distributed continuous variables using the Student's t-test, and non-parametric and ordinal variables using the Wilcoxon Rank sum test.

Study Type

Observational

Enrollment (Actual)

168

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • University of Colorado-Denver
    • Texas
      • San Antonio, Texas, United States, 78234
        • Brooke Army Medical Center

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We are seeking all patients undergoing intubation for which the clinician chooses to use VL.

Description

Inclusion Criteria:

  • We are seeking any encounter for which the patient undergoes VL intubation as part of routine clinical care.

Exclusion Criteria:

  • No intubation will be excluded so long as VL is used.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Video Laryngoscopy
Seeking all patients undergoing intubation for which the clinician chooses to use Video Laryngoscopy. The participants will undergo intubation with the investigators chosen device.
Device: I View Video Laryngoscope https://www.intersurgical.com/content/files/108253/-1977057700
All intubations will be performed at the direction of the attending clinician. The decision to intubate is based purely on clinical factors by the primary team. The decision to use VL device will be at the direction of the clinical team. No patient will be recruited specific for this procedure.
Other Names:
  • GlideScope 00879123006400
  • Storz C-Mac 04048551409381

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation first-pass success rate
Time Frame: Peri-procedural
First-pass success between the i-view and the durable VL devices.
Peri-procedural

Collaborators and Investigators

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

Sponsor

Brooke Army Medical Center

Collaborators

University of Colorado, Denver

Investigators

  • Principal Investigator: Steven G Schauer, DO, U.S. army Institute of Surgical Research

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

Helpful Links

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)

June 23, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21-022

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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