NCT04907695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

June 23, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

May 10, 2021

Last Update Submit

February 7, 2025

Conditions

Keywords

Video laryngoscopyReusable Video Laryngoscopy devices

Outcome Measures

Primary Outcomes (1)

  • Intubation first-pass success rate

    First-pass success between the i-view and the durable VL devices.

    Peri-procedural

Study Arms (1)

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

Interventions

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.

Also known as: GlideScope 00879123006400, Storz C-Mac 04048551409381
Video Laryngoscopy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado-Denver

Denver, Colorado, 80204, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related 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 Registry Study. Ann Emerg Med. 2018 Dec;72(6):645-653. doi: 10.1016/j.annemergmed.2018.03.042. Epub 2018 May 7.

  • 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 Registry study. US Army Med Dep J. 2017 Oct-Dec;(3-17):98-104.

  • 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 Jul;71(1 Suppl):S4-8. doi: 10.1097/TA.0b013e318221147b.

  • 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 for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc.

  • 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.

  • 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.

  • 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.

  • Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. doi: 10.1111/j.1365-2044.2004.04013.x.

  • Serocki G, Bein B, Scholz J, Dorges 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.0b013e32832d328d.

  • 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. 2022 May 3;187(5-6):e572-e576. doi: 10.1093/milmed/usaa537.

  • 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. Resuscitation. 2021 May;162:403-411. doi: 10.1016/j.resuscitation.2021.02.039. Epub 2021 Mar 5.

Related Links

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Steven G Schauer, DO

    U.S. Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician Scientist

Study Record Dates

First Submitted

May 10, 2021

First Posted

June 1, 2021

Study Start

June 23, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations