Videolaryngoscope vs Regular Laryngoscope for Infant Intubation

(NasoVISI Trial)

No longer recruiting at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which tool better assists infants in breathing during certain heart procedures: a video laryngoscope (a camera-equipped device) or a regular laryngoscope (a traditional tool). It focuses on babies requiring breathing tubes during planned heart surgeries or procedures. The trial seeks infants scheduled for these surgeries who will receive anesthesia. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance surgical outcomes for infants.

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 prior data suggests that these intubation techniques are safe for infants?

Research shows that using a video camera to assist with intubating infants is generally well-received. Studies indicate that this method, called videolaryngoscopy (VL), facilitates successful first-attempt insertion of the breathing tube compared to the traditional method, direct laryngoscopy (DL). Fewer attempts can lower the risk of complications. Both methods—VL and DL—are considered safe, with no major differences in reported side effects.

Although specific information on serious side effects for either method is lacking, successful first-attempt intubation is crucial. Fewer attempts can lead to fewer complications. Overall, both methods are safe for infants, but VL may reduce the number of attempts needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the comparison between videolaryngoscopy and direct laryngoscopy for infant intubation because of the potential advantages videolaryngoscopy offers. Unlike the traditional direct laryngoscopy, which relies on direct line-of-sight, videolaryngoscopy uses a camera system that provides a clear, magnified view of the infant's airway on a screen. This enhanced visibility could lead to more accurate and quicker intubation, reducing the risk of complications and improving outcomes. By investigating these differences, the trial aims to determine whether videolaryngoscopy can become a superior method for infant intubation.

What evidence suggests that this trial's techniques could be effective for infant intubation?

This trial will compare videolaryngoscopy (VL) with direct laryngoscopy (DL) for nasotracheal intubation in infants. Research has shown that using a video camera to assist in placing a breathing tube (VL) can increase the likelihood of success on the first attempt in newborns, compared to the traditional method without a camera (DL). One study found that VL reduced the risk of incorrect tube placement in babies under one year old. Both methods require a similar number of attempts and time to complete. However, VL clearly excels in achieving correct placement on the first try, suggesting it might be more effective and safer for infants needing a breathing tube through the nose. ^{1 3 5 6 7}

Who Is on the Research Team?

Annery Garcia-Marcinikiewicz, MD

Principal Investigator

The Children Hospital of Philadelphia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03032263

Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation The objective of this study is to compare the need for the use of standard Magill forceps when performing a nasal intubation with either conventional DL or VL ...

2. vanderbilt.trialstoday.org vanderbilt.trialstoday.org/trial/NCT05433155

Nasotracheal Intubation With VL vs DL in Infants Trial 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225006002

Review Article Videolaryngoscopy versus ... In infants (<1 yr), VL significantly reduced the risk of oesophageal intubation compared with DL (RR: 0.16, 95% CI: 0.1–0.4). In children (≥1 yr) ...

4. apsf.org apsf.org/grants-and-awards/grant-recipients/nasotracheal-intubation-with-videolaryngoscopy-versus-direct-laryngoscopy-in-infants-nasovisi-trial/

Nasotracheal Intubation with Videolaryngoscopy versus ... There is currently no published data on whether VL is more effective than DL at improving first-attempt NTI success rates and reducing complications in infants.

5. bmjpaedsopen.bmj.com bmjpaedsopen.bmj.com/content/7/1/e001958

Video versus direct laryngoscopy to improve the success ... Video versus direct laryngoscopy to improve the success rate of nasotracheal intubations in the neonatal intensive care setting: a randomised ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210844024001631

Direct laryngoscopy versus videolaryngoscopy for neonatal ... Efficacy outcomes and safety outcomes. Our efficacy outcomes focused on first-attempt intubation success rate, time to intubate, and average number of attempts.

7. bjanaesthesia.org bjanaesthesia.org/article/S0007-0912(25)00600-2/fulltext

a systematic review with meta-analysis and trial sequential ... Multiple intubation attempts increase the risk of severe complications; therefore, achieving high first-pass success is critical.