VISI: The Videolaryngoscopy in Small Infants

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03396432
• Collaborator: Anesthesia Patient Safety Foundation (Other)
• Enrollment: 566
• Locations: 5
• Arms: 2
• Actual Duration (Months): 30.9
• Patients Per Site: 113.2
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Anesthesia, Endotracheal	Device: Video Laryngoscopy for ET placement; Device: Direct Laryngoscopy for ET Placement	N/A

Detailed Description

Objectives:

• Primary Objective To compare the tracheal intubation (TI) first attempt success rate using VL vs. DL in children ≤ 12 months old.

• Secondary Objectives To compare the lowest oxygen saturation during tracheal intubation with VL vs. DL.

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:

• The first intubation attempt success rate with each device

• The number of attempts for successful intubation with each device

• Complications associated with intubation

Study Design

• Study Type: Interventional
• Actual Enrollment: 566 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, randomized, multi-center parallel group trialProspective, randomized, multi-center parallel group trial
• Masking: Single (Outcomes Assessor)
• Masking Description: Statistician will be blinded at the time of data analysis.
• Primary Purpose: Other
• Official Title: The Videolaryngoscopy in Small Infants (VISI) Trial
• Actual Study Start Date: Jun 4, 2018
• Actual Primary Completion Date: Aug 19, 2019
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Video Laryngoscopy for endotracheal (ET) Placement Device: Storz C-MAC Video Laryngoscope	Device: Video Laryngoscopy for ET placement; Tracheal intubation performed with the Storz C-Mac Video Laryngoscope; Device: Direct Laryngoscopy for ET Placement; Tracheal Intubation performed with the Miller Blade
Active Comparator: Direct Laryngoscopy for ET Placement Device: Miller Laryngoscope	Device: Video Laryngoscopy for ET placement; Tracheal intubation performed with the Storz C-Mac Video Laryngoscope; Device: Direct Laryngoscopy for ET Placement; Tracheal Intubation performed with the Miller Blade

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Success in the First Attempt [at the time of intubation]

   comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL

Secondary Outcome Measures

1. Hypoxia [At the time of intubation]

   Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Males or females age 0 to <12 months.

2. Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under general anesthesia where oral endotracheal intubation will be performed by an anesthesiology clinician.

3. Subject/Parental/guardian permission (informed consent).

Inclusion for clinician participants:

1. Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident

Exclusion Criteria

1. History of difficult intubation

2. History with abnormal airway

3. Predictive of difficult intubation upon physical examination

4. Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115
2	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
3	UT Southwestern Medical Center	Dallas	Texas	United States	75390
4	Seattle Children's Hospital	Seattle	Washington	United States	98105
5	Princess Margaret Hospital For Children	Subiaco	Perth	Australia

Sponsors and Collaborators

• Children's Hospital of Philadelphia
• Anesthesia Patient Safety Foundation

Investigators

• Principal Investigator: John Fiadjoe, MD, Children's Hospital of Philadelphia

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 31, 2018
• Informed Consent Form - Feb 26, 2018

More Information

Publications

• 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:CD011413. doi: 10.1002/14651858.CD011413.pub2. Review.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Review. Update in: Cochrane Database Syst Rev. 2018 Jun 04;6:CD009975.
• Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents.
• 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.
• 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.
• Souza Nd, Carvalho WB. [Complications of tracheal intubation in pediatrics]. Rev Assoc Med Bras (1992). 2009 Nov-Dec;55(6):646-50. Portuguese.
• 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.

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT03396432
• Other Study ID Numbers: 17-014302
• First Posted: Jan 11, 2018
• Last Update Posted: Mar 25, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Children's Hospital of Philadelphia: laryngoscope; intubation; first attempt success; oxygen saturation; airway management; Videolaryngoscopy; Direct laryngoscopy

Study Results

Participant Flow

Recruitment Details	The study was recruited per protocol without any protocol deviation or violation.
Pre-assignment Detail	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.

Arm/Group Title	Video Laryngoscopy for Endotracheal (ET) Placement	Direct Laryngoscopy for ET Placement
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	283	283
COMPLETED	274	277
NOT COMPLETED	9	6

Baseline Characteristics

Arm/Group Title	Video Laryngoscopy for Endotracheal (ET) Placement	Direct Laryngoscopy for ET Placement	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	274	277	551
Age, Customized (Count of Participants)
0-30 Days	17 6.2%	20 7.2%	37 6.7%
31-90 Days	55 20.1%	64 23.1%	119 21.6%
> 90 Days	202 73.7%	193 69.7%	395 71.7%
Sex: Female, Male (Count of Participants)
Female	79 28.8%	96 34.7%	175 31.8%
Male	195 71.2%	181 65.3%	376 68.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Weight (kg) (kg) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg]	6.5	6.6	6.5
ASA (Count of Participants)
1 - Normal	58 21.2%	72 26%	130 23.6%
2 - Mild systemic disease	133 48.5%	136 49.1%	269 48.8%
>= 2 - Mod - Severe systemic disease	83 30.3%	69 24.9%	152 27.6%
Induction Technique -IV (Count of Participants)
Count of Participants [Participants]	28 10.2%	39 14.1%	67 12.2%
Muscle Relaxant (Count of Participants)
None	15 5.5%	14 5.1%	29 5.3%
Succinylcholine	9 3.3%	11 4%	20 3.6%
Other	250 91.2%	252 91%	502 91.1%
Device experience as number of infant intubations (Count of Participants)
0	38 13.9%	10 3.6%	48 8.7%
1-10	79 28.8%	59 21.3%	138 25%
11-20	36 13.1%	36 13%	72 13.1%
21-50	49 17.9%	37 13.4%	86 15.6%
>50	62 22.6%	128 46.2%	190 34.5%
Unknown	10 3.6%	7 2.5%	17 3.1%
Provider Role (Count of Participants)
Anes Attending	69 25.2%	69 24.9%	138 25%
Anes Fellow	99 36.1%	102 36.8%	201 36.5%
Anes Resident	106 38.7%	106 38.3%	212 38.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Success in the First Attempt
Description	comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL
Time Frame	at the time of intubation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video Laryngoscopy for Endotracheal (ET) Placement	Direct Laryngoscopy for ET Placement
Arm/Group Description	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	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
Measure Participants	274	277
Count of Participants [Participants]	253 92.3%	243 87.7%

2. Secondary Outcome

Title	Hypoxia
Description	Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL
Time Frame	At the time of intubation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video Laryngoscopy for Endotracheal (ET) Placement	Direct Laryngoscopy for ET Placement
Arm/Group Description	Device: Storz C-MAC Video Laryngoscope Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope	Device: Miller Laryngoscope Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
Measure Participants	274	277
Count of Participants [Participants]	9 3.3%	15 5.4%

Adverse Events

Time Frame	Upon discharge from PACU or up to 24 hr after intubation
Arm/Group Title	Video Laryngoscopy for Endotracheal (ET) Placement		Direct Laryngoscopy for ET Placement
Arm/Group Description	Device: Storz C-MAC Video Laryngoscope Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope		Device: Miller Laryngoscope Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
All Cause Mortality
	Video Laryngoscopy for Endotracheal (ET) Placement		Direct Laryngoscopy for ET Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/274 (0%)		0/277 (0%)
Serious Adverse Events
	Video Laryngoscopy for Endotracheal (ET) Placement		Direct Laryngoscopy for ET Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/274 (0%)		0/277 (0%)
Other (Not Including Serious) Adverse Events
	Video Laryngoscopy for Endotracheal (ET) Placement		Direct Laryngoscopy for ET Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/274 (1.1%)		2/277 (0.7%)
Cardiac disorders
Intermittent tachypnea	1/274 (0.4%)	1	0/277 (0%)	0
Respiratory, thoracic and mediastinal disorders
Stridor	0/274 (0%)	0	1/277 (0.4%)	1
Brief Desaturation	2/274 (0.7%)	3	1/277 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.