Videolaryngoscope vs Regular Laryngoscope for Infant Intubation

(NasoVISI Trial)

Recruiting at 9 trial locations

Overseen By Paula Hu, MSPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must be taking: Neuromuscular blockers

Disqualifiers: Less than 36 weeks, Less than 2 kg, History of difficult intubation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

680 Participants Needed

Trial Summary

What is the purpose of this trial?

Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications. However, it mentions that a neuromuscular blocking drug will be used before intubation as part of standard care.

What data supports the effectiveness of this treatment for infant intubation?

Research suggests that videolaryngoscopy (VL) can be an effective tool for training inexperienced medical staff in tracheal intubation, as it improves success rates and reduces intubation time compared to direct laryngoscopy (DL). This indicates that VL might be beneficial for infant intubation, especially for those new to the procedure. ^{1 2 3 4 5}

Is nasotracheal intubation with videolaryngoscopy safe for infants?

Research suggests that using videolaryngoscopy for intubation in newborns may reduce the risk of adverse events (unwanted side effects or complications) compared to traditional methods. ^{1 2 4 5 6}

How does nasotracheal intubation with videolaryngoscopy differ from other treatments for infant intubation?

Nasotracheal intubation with videolaryngoscopy (VL) offers an indirect view of the airway, which can be especially helpful for inexperienced users, as it allows them to see the airway on a screen without needing to align the oral and throat passages. This can lead to higher success rates and shorter intubation times for novices compared to direct laryngoscopy (DL), which requires direct line-of-sight and more skill. ^{1 3 4 5 7}

Research Team

Annery Garcia-Marcinikiewicz, MD

Principal Investigator

The Children Hospital of Philadelphia

Eligibility Criteria

This trial is for infants aged 0-365 days who need general anesthesia for elective cardiothoracic surgery or cardiac catheterization. They must be scheduled to receive a muscle relaxant before intubation and have no history of difficult intubation, abnormal airway, preoperative breathing tubes, or tracheostomy. Infants born before 36 weeks gestation or weighing less than 2 kg are excluded.

Inclusion Criteria

I am a newborn, less than 1 year old.

Parental/guardian permission (informed consent)

I will be given a muscle relaxant before being put on a breathing tube.

Exclusion Criteria

You have had a hard time breathing with a tube in your throat in the past.

You are not at least 36 weeks pregnant.

My weight is under 2 kg.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo nasotracheal intubation using either Videolaryngoscopy or Direct Laryngoscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for complications and success rate of intubation

24 hours

1 visit (in-person)

Treatment Details

Interventions

• Nasotracheal Intubation

Trial Overview The NasoVISI Trial compares two methods of nasotracheal intubation in infants: Videolaryngoscopy (VL) using the Storz C-Mac Video system versus Standard Direct Laryngoscopy (DL). The study aims to determine which method has a higher first attempt success rate during surgeries and procedures lasting over 30 minutes.

Participant Groups

Group I: Videolaryngoscopy Active Control 1 Intervention

Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope

Group II: Direct Laryngoscopy Active Control 1 Intervention

Nasotracheal Intubation performed with the standard clinical direct blades

Nasotracheal Intubation is already approved in United States for the following indications:

Approved in United States as Nasotracheal Intubation for:

• Cardiothoracic surgery
• Cardiac catheterizations

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Dell Children's Medical Center of Central Texas

Collaborator

Trials

7

Recruited

5,004,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Children's Medical Center Dallas

Collaborator

Trials

23

Recruited

5,012,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+

Findings from Research

Videolaryngoscopy (VL) does not significantly increase the overall success rate of nasotracheal intubation (NTI) compared to direct laryngoscopy (DL), but it does improve the first-attempt success rate and reduces intubation time, especially for patients with difficult airways.

In a review of 14 studies involving 1052 adult surgical patients, VL was associated with better laryngeal visualization and a lower incidence of postoperative sore throat, indicating it may be a safer and more effective option in certain scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Videolaryngoscopy versus direct laryngoscopy for nasotracheal intubation: A systematic review and meta-analysis of randomised controlled trials. Jiang, J., Ma, DX., Li, B., et al.[2019]

The GlideScope videolaryngoscope (GVL) significantly reduced the time to intubation (TTI) by an average of 23.2 seconds compared to direct laryngoscopy (DL), making it a faster option for nasotracheal intubation in 70 patients.

Intubation was easier with the GVL, as indicated by a lower score on the Visual Analog Scale for ease of intubation, and it also resulted in a lower incidence of moderate to severe postoperative sore throat (9% vs 34% for DL), highlighting its advantages in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. Jones, PM., Armstrong, KP., Armstrong, PM., et al.[2022]

In a study comparing video laryngoscopy (VL) and direct laryngoscopy (DL) for neonatal tracheal intubation (NTI), experienced medical staff (EMS) had a significantly lower success rate and longer intubation time with VL compared to DL, indicating that VL may not be as effective for skilled practitioners in this context.

However, for novice midwives, VL resulted in a significantly shorter intubation time and higher success rate compared to DL, suggesting that VL can be a valuable training tool for inexperienced staff learning NTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video Laryngoscopy Improves the Success of Neonatal Tracheal Intubation for Novices but Not for Experienced Medical Staff. Zhou, M., Xi, X., Li, M., et al.[2020]

In a study comparing endotracheal intubation techniques using a pediatric manikin, experienced users had similar intubation times with videolaryngoscopy (CMAC) and direct laryngoscopy (Miller and Macintosh), but the GlideScope took significantly longer.

Both experienced and inexperienced users found that standard laryngoscopes (Miller and Macintosh) and the CMAC were faster and more effective for intubation compared to the GlideScope, suggesting that traditional methods may be preferable in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Direct Laryngoscopy and Videolaryngoscopy for Endotracheal Intubation by Inexperienced Users: A Pediatric Manikin Study. Balaban, O., Hakim, M., Walia, H., et al.[2020]

Video laryngoscopy (VL) significantly reduces the time to nasotracheal intubation (NTI) compared to direct laryngoscopy (DL), with a mean difference of -9.04 seconds based on a meta-analysis of 10 studies involving various oromaxillofacial surgeries.

VL also increases the first attempt success rate for intubation and requires fewer maneuvers to facilitate the process, making it a recommended first-line device for NTI in experienced hands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video laryngoscopy vs. direct laryngoscopy for nasotracheal intubation in oromaxillofacial surgery: a systematic review and meta-analysis of randomized controlled trials. Gupta, N., Gupta, A., Sarma, R., et al.[2021]

A retrospective cohort study found that using video laryngoscopy during neonatal tracheal intubation is linked to a reduced risk of adverse events.

This suggests that video laryngoscopy may improve safety during the intubation process in newborns, although the specific details of the study's methods and participant numbers were not provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit. Pouppirt, NR., Nassar, R., Napolitano, N., et al.[2019]

Videolaryngoscopy (VL) offers a shared airway view for both the intubator and supervisor, enhancing the success rate of neonatal intubation, but the shape differences between VL and conventional laryngoscope (CL) blades may require slight adjustments in technique.

VL blades have a narrower direct airway view compared to CL blades, despite maintaining a clear view on the VL screen, suggesting that modifying VL blade designs could improve their effectiveness as training tools for intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of conventional and videolaryngoscopy blades in neonates. Kirolos, S., O'Shea, JE.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Videolaryngoscopy versus direct laryngoscopy for nasotracheal intubation: A systematic review and meta-analysis of randomised controlled trials. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Video Laryngoscopy Improves the Success of Neonatal Tracheal Intubation for Novices but Not for Experienced Medical Staff. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Direct Laryngoscopy and Videolaryngoscopy for Endotracheal Intubation by Inexperienced Users: A Pediatric Manikin Study. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Video laryngoscopy vs. direct laryngoscopy for nasotracheal intubation in oromaxillofacial surgery: a systematic review and meta-analysis of randomized controlled trials. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Comparison of conventional and videolaryngoscopy blades in neonates. [2022]