Comparing iView Video Laryngoscope in the Emergency Department

Intubation; Difficult or Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04907695
• Other study ID #: H-21-022
• Status: Active, not recruiting
• Start date: June 23, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2022
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Emergencies
• Intubation; Difficult or Failed

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado-Denver	Denver	Colorado
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Brooke Army Medical Center	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (11)

April MD, Arana A, Pallin DJ, Schauer SG, Fantegrossi A, Fernandez J, Maddry JK, Summers SM, Antonacci MA, Brown CA 3rd; NEAR Investigators. Emergency Department Intubation Success With Succinylcholine Versus Rocuronium: A National Emergency Airway Regist — View Citation

April MD, Arana A, Reynolds JC, Carlson JN, Davis WT, Schauer SG, Oliver JJ, Summers SM, Long B, Walls RM, Brown CA 3rd; NEAR Investigators. Peri-intubation cardiac arrest in the Emergency Department: A National Emergency Airway Registry (NEAR) study. Res — View Citation

April MD, Schauer SG, Brown Rd CA, Ng PC, Fernandez J, Fantegrossi AE, Maddry JK, Summers S, Sessions DJ, Barnwell RM, Antonacci M. A 12-month descriptive analysis of emergency intubations at Brooke Army Medical Center: a National Emergency Airway Registr — View Citation

Deakin CD, King P, Thompson F. Prehospital advanced airway management by ambulance technicians and paramedics: is clinical practice sufficient to maintain skills? Emerg Med J. 2009 Dec;26(12):888-91. doi: 10.1136/emj.2008.064642. — View Citation

Eastridge BJ, Hardin M, Cantrell J, Oetjen-Gerdes L, Zubko T, Mallak C, Wade CE, Simmons J, Mace J, Mabry R, Bolenbaucher R, Blackbourne LH. Died of wounds on the battlefield: causation and implications for improving combat casualty care. J Trauma. 2011 J — View Citation

Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications — View Citation

Liao CC, Liu FC, Li AH, Yu HP. Video laryngoscopy-assisted tracheal intubation in airway management. Expert Rev Med Devices. 2018 Apr;15(4):265-275. doi: 10.1080/17434440.2018.1448267. Epub 2018 Mar 12. Review. — View Citation

Pott LM, Murray WB. Review of video laryngoscopy and rigid fiberoptic laryngoscopy. Curr Opin Anaesthesiol. 2008 Dec;21(6):750-8. doi: 10.1097/ACO.0b013e3283184227. Review. — View Citation

Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. — View Citation

Schauer SG, Davis WT, Johnson MD, Escandon MA, Uhaa N, Maddry JK, Naylor JF, Van Arnem KA, April MD. A Prospective Assessment of a Novel, Disposable Video Laryngoscope With Physician Assistant Trainees Using a Synthetic Cadaver Model. Mil Med. 2020 Dec 8. — View Citation

Serocki G, Bein B, Scholz J, Dörges V. Management of the predicted difficult airway: a comparison of conventional blade laryngoscopy with video-assisted blade laryngoscopy and the GlideScope. Eur J Anaesthesiol. 2010 Jan;27(1):24-30. doi: 10.1097/EJA.0b01 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation first-pass success rate	First-pass success between the i-view and the durable VL devices.	Peri-procedural

External Links

•   GlideScope
•   I-view
•   Storz C-Mac