Comparing iView Video Laryngoscope in the Emergency Department
NCT ID: NCT04907695
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
168 participants
OBSERVATIONAL
2021-06-23
2023-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial
NCT02208349
Prehospital Tracheal Intubation Technique Using Initial Direct Laryngoscopy During Videolaryngoscopy
NCT06918717
King Vision® and GlideScope® in Difficult Airways
NCT03685968
Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
NCT04930419
Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management
NCT01710891
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Colorado, Denver
OTHER
Brooke Army Medical Center
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Steven Schauer
Physician Scientist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven G Schauer, DO
Role: PRINCIPAL_INVESTIGATOR
U.S. Army Institute of Surgical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado-Denver
Denver, Colorado, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-21-022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.