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| Name | Class |
|---|---|
| Anesthesia Patient Safety Foundation | OTHER |
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Complications related to infant (≤ 1 year) airway management are under-appreciated because of few rigorous and targeted studies. Investigators have recently shown that multiple tracheal intubation (TI) attempts are a key risk factor for intubation-related complications in small children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in anesthesiology practice because of several advantages over conventional direct laryngoscopy (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer intubation attempts, but may take more time to intubate the trachea. This study compares first attempt success of VL to DL in infants presenting for elective surgery.
Objectives:
Study Design:
Prospective, randomized, multi-center parallel group trial
Setting/Participants:
This will be a multi-center study with a minimum of four participating centers. The target population will be children ≤ 12 months age scheduled for elective surgery requiring general anesthesia with endotracheal intubation.
Study Interventions and Measures:
The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Miller 1 (VL) or the conventional Miller laryngoscope (DL).
Main study outcome measures are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Laryngoscopy for endotracheal (ET) Placement | Active Comparator | Device: Storz C-MAC Video Laryngoscope |
|
| Direct Laryngoscopy for ET Placement | Active Comparator | Device: Miller Laryngoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Laryngoscopy for ET placement | Device | Tracheal intubation performed with the Storz C-Mac Video Laryngoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Success in the First Attempt | comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL | at the time of intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxia | Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL | At the time of intubation |
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Inclusion Criteria
Inclusion for clinician participants:
1) Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| John Fiadjoe, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| The Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26705976 | Background | Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17. | |
| 26177215 |
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The block size was varying among 2, 4, 6 to avoid the predictability of device assignment. To further balance device assignment, we'll stratify the randomization by study site and clinician's role. Separate randomization schedule was generated for each stratum.
The study was recruited per protocol without any protocol deviation or violation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Video Laryngoscopy for Endotracheal (ET) Placement | Device: Storz C-MAC Video Laryngoscope Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade |
| FG001 | Direct Laryngoscopy for ET Placement | Device: Miller Laryngoscope Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
566 subjects enrolled with 551 evaluable
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| ID | Title | Description |
|---|---|---|
| BG000 | Video Laryngoscopy for Endotracheal (ET) Placement | Device: Storz C-MAC Video Laryngoscope Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Success in the First Attempt | comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL | Posted | Count of Participants | Participants | at the time of intubation |
|
Upon discharge from PACU or up to 24 hr after intubation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Video Laryngoscopy for Endotracheal (ET) Placement | Device: Storz C-MAC Video Laryngoscope Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stridor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Cleft palate repair-Possibly related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Fiadjoe, PI | Children Hospital of Philadelphia | 267-426-2961 | fiadjoej@email.chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2018 | Apr 2, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2018 | Apr 2, 2020 | ICF_001.pdf |
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Prospective, randomized, multi-center parallel group trial
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Statistician will be blinded at the time of data analysis.
| Direct Laryngoscopy for ET Placement | Device | Tracheal Intubation performed with the Miller Blade |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Princess Margaret Hospital For Children | Subiaco | Perth | Australia |
| Background |
| Sun H, Liu M, Lin Z, Jiang H, Niu Y, Wang H, Chen S. Comprehensive identification of 125 multifarious constituents in Shuang-huang-lian powder injection by HPLC-DAD-ESI-IT-TOF-MS. J Pharm Biomed Anal. 2015 Nov 10;115:86-106. doi: 10.1016/j.jpba.2015.06.013. Epub 2015 Jun 30. |
| 25691129 | Background | Lingappan K, Arnold JL, Shaw TL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2015 Feb 18;(2):CD009975. doi: 10.1002/14651858.CD009975.pub2. |
| 25700237 | Background | Goto T, Gibo K, Hagiwara Y, Morita H, Brown DF, Brown CA 3rd, Hasegawa K; Japanese Emergency Medicine Network Investigators. Multiple failed intubation attempts are associated with decreased success rates on the first rescue intubation in the emergency department: a retrospective analysis of multicentre observational data. Scand J Trauma Resusc Emerg Med. 2015 Jan 16;23:5. doi: 10.1186/s13049-014-0085-8. |
| 25552546 | Background | Goto T, Watase H, Morita H, Nagai H, Brown CA 3rd, Brown DF, Hasegawa K; Japanese Emergency Medicine Network Investigators. Repeated attempts at tracheal intubation by a single intubator associated with decreased success rates in emergency departments: an analysis of a multicentre prospective observational study. Emerg Med J. 2015 Oct;32(10):781-6. doi: 10.1136/emermed-2013-203473. Epub 2014 Dec 31. |
| 23574475 | Background | Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055. |
| 15271750 | Background | Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15. |
| 20191217 | Background | Souza Nd, Carvalho WB. [Complications of tracheal intubation in pediatrics]. Rev Assoc Med Bras (1992). 2009 Nov-Dec;55(6):646-50. Portuguese. |
| 28492404 | Background | Grunwell JR, Kamat PP, Miksa M, Krishna A, Walson K, Simon D, Krawiec C, Breuer R, Lee JH, Gradidge E, Tarquinio K, Shenoi A, Shults J, Nadkarni V, Nishisaki A; National Emergency Airway Registry for Children (NEAR4KIDS) and the Pediatric Acute Lung Injury and Sepsis (PALISI) Network. Trend and Outcomes of Video Laryngoscope Use Across PICUs. Pediatr Crit Care Med. 2017 Aug;18(8):741-749. doi: 10.1097/PCC.0000000000001175. |
| 28539007 | Background | Abdelgadir IS, Phillips RS, Singh D, Moncreiff MP, Lumsden JL. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in children (excluding neonates). Cochrane Database Syst Rev. 2017 May 24;5(5):CD011413. doi: 10.1002/14651858.CD011413.pub2. |
| 19104167 | Background | Nouruzi-Sedeh P, Schumann M, Groeben H. Laryngoscopy via Macintosh blade versus GlideScope: success rate and time for endotracheal intubation in untrained medical personnel. Anesthesiology. 2009 Jan;110(1):32-7. doi: 10.1097/ALN.0b013e318190b6a7. |
| 18676418 | Background | Howard-Quijano KJ, Huang YM, Matevosian R, Kaplan MB, Steadman RH. Video-assisted instruction improves the success rate for tracheal intubation by novices. Br J Anaesth. 2008 Oct;101(4):568-72. doi: 10.1093/bja/aen211. Epub 2008 Aug 1. |
| 33308472 | Derived | Garcia-Marcinkiewicz AG, Kovatsis PG, Hunyady AI, Olomu PN, Zhang B, Sathyamoorthy M, Gonzalez A, Kanmanthreddy S, Galvez JA, Franz AM, Peyton J, Park R, Kiss EE, Sommerfield D, Griffis H, Nishisaki A, von Ungern-Sternberg BS, Nadkarni VM, McGowan FX Jr, Fiadjoe JE; PeDI Collaborative investigators. First-attempt success rate of video laryngoscopy in small infants (VISI): a multicentre, randomised controlled trial. Lancet. 2020 Dec 12;396(10266):1905-1913. doi: 10.1016/S0140-6736(20)32532-0. |
| Direct Laryngoscopy for ET Placement |
Device: Miller Laryngoscope Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight (kg) | Median | Inter-Quartile Range | kg |
|
| ASA | Count of Participants | Participants |
|
| Induction Technique -IV | Count of Participants | Participants |
|
| Muscle Relaxant | Count of Participants | Participants |
|
| Device experience as number of infant intubations | Count of Participants | Participants |
|
| Provider Role | Count of Participants | Participants |
|
|
|
| Secondary | Hypoxia | Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL | Posted | Count of Participants | Participants | At the time of intubation |
|
|
|
| 0 |
| 274 |
| 0 |
| 274 |
| 3 |
| 274 |
| EG001 | Direct Laryngoscopy for ET Placement | Device: Miller Laryngoscope Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade | 0 | 277 | 0 | 277 | 2 | 277 |
|
| Intermittent tachypnea | Cardiac disorders | Systematic Assessment | History of respiratory failure-Not related |
|
| Brief Desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Probably not related |
|
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