Clinical trial NCT04907695: Comparing iView Video Laryngoscope in the Emergency Department
Official title: A Prospective Comparison of the Disposable I-view Versus the Durable Video Laryngoscopes in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation; Difficult or Failed
Airway Obstruction
Keywords: Video laryngoscopy
Reusable Video Laryngoscopy devices
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: University of Colorado, Denver
First posted: 2021-06-01
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are seeking all patients undergoing intubation for which the clinician chooses to use VL.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intubation first-pass success rate
timeFrame: Peri-procedural
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado-Denver
state: Colorado
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: U.S. Army Institute of Surgical Research
name: Steven G Schauer, DO
role: PRINCIPAL_INVESTIGATOR
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