100 Participants NeededMy employer runs this trial

Intubation Blades for C-Section

(ANGLED Trial)

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Overseen ByFabricio B Zasso, MD
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of video laryngoscope blade is more effective for intubating pregnant patients during a C-section under general anesthesia. A video laryngoscope assists doctors in placing a breathing tube. The trial compares two blade types: the Macintosh style with a gentle curve and the hyperangulated with a sharper curve. As a feasibility study, it assesses whether enough participants will join and if the study methods function effectively. Pregnant patients requiring an emergency or urgent C-section with a breathing tube are suitable candidates. As an unphased trial, this study allows participants to contribute to the improvement of medical procedures for future patients.

What prior data suggests that these intubation blades are safe for cesarean sections?

Research has shown that both hyperangulated and Macintosh-style blades have been safely used in medical settings for about 20 years. One study suggested that hyperangulated blades can ease intubation by reducing the number of attempts needed, thereby lowering the risk of complications. Another study found that these blades might also help prevent breathing problems in certain situations, leading to fewer negative outcomes.

For the Macintosh-style blade, research indicates it is effective and quick for intubation in many cases. Its widespread use in emergency and anesthesia care supports its safety and reliability.

Both blades are generally well-tolerated, with no major side effects commonly reported. Their long history of use in surgeries suggests they are considered safe options for intubation during cesarean sections.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different intubation blade styles used during C-sections, which could improve safety and efficiency. The Hyperangulated blade offers a unique angle that may provide better visibility and easier access to the airway, potentially reducing intubation complications. On the other hand, the Macintosh style blade is a widely used standard that serves as a benchmark for comparison. By investigating these two methods, researchers hope to identify which blade offers the safest and most effective option for intubating patients undergoing C-sections.

What evidence suggests that these intubation blades are effective for cesarean sections?

This trial will compare hyperangulated blades and Macintosh-style blades for intubation during cesarean sections. Studies have shown that both blade types effectively assist breathing during cesarean sections under general anesthesia. Research indicates that the hyperangulated blade achieves a high success rate on the first attempt, with one study showing a 96.2% success rate, and often requires fewer attempts. The Macintosh-style blade, widely used and effective in many situations, may not perform as well in some cases. Both blades have been used safely for many years, and evidence supports their effectiveness for breathing assistance during surgeries like cesarean deliveries.678910

Are You a Good Fit for This Trial?

This trial is for pregnant individuals scheduled for a C-section who will need general anesthesia with intubation. People may not be eligible if they have conditions that make intubation unsafe or are unable to participate as determined by the study team.

Inclusion Criteria

I am pregnant and need an emergency or urgent C-section with general anesthesia and intubation.

Exclusion Criteria

Patients that previously participated in the study
I have never had a tube placed in my windpipe for breathing.
I do not agree to participate in this study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are intubated using either a Macintosh style blade or a Hyperangulated blade during cesarean delivery under general anesthesia

16 months

Follow-up

Participants are monitored for airway-related morbidity, including minor oral or dental injuries and postoperative sore throat, with a follow-up call on postoperative day 3

3 days

What Are the Treatments Tested in This Trial?

Interventions

  • Hyperangulated Blade
  • Macintosh Style Blade

Trial Overview

The study compares two types of video laryngoscope blades—a Macintosh-style blade (gentle curve) and a hyperangulated blade (sharper curve)—to see which works better for placing breathing tubes during general anesthesia in C-sections. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Macintosh style bladeActive Control1 Intervention
Group II: Hyperangulated bladeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials
132
Recruited
11,400+

Citations

First-Attempt Intubation Success of Video Laryngoscopy in ...

Intubation success rate on first attempt was 96.2% in the GlideScope group and 93.4% in the C-MAC D-Blade group. hyperangulated ...

Techniques for Improving Video Laryngoscopy With a ...

When using the GlideScope hyperangulated blade, all 3 years of residents had lower intubation times compared to attending physicians and they ...

Factors Influencing the Time of Intubation Using C-MAC D ...

Results The mean time to intubate was the least with 100-degree angulation in group C (19.60 ± 0.97) while the maximum time was in group A with 80-degree ...

Difficult and failed intubation in Caesarean general ...

There were 33 difficult intubations among 660 patients, Junior trainees performed about 90% of all intubations and 28 (84.8%) out of 33 difficult intubations.

Hyperangulated Video Laryngoscopy Beneficial for ...

hyperangulated video laryngoscopy reduces the number of attempts needed to achieve intubation, according to a study

Techniques for Improving Video Laryngoscopy With a ...

This hyper-angulated shape usually requires the use of a correspondingly curved stylet, such as the GlideRite stylet, to guide the endotracheal ...

A comparison of two hyperangulated video laryngoscope ...

The higher FPAs of hyperangulated blades in DA may avoid desaturations and decrease adverse events in pediatric airway management.

How to get the best view for airway intubation with video ...

This video provides the features of the BESDATA BD-DF Reusable Video Laryngoscope, blade types and how to use it for airway intubation.