Laryngoscope Blades for Critical Illness

(ANGLE Trial)

Not yet recruiting at 1 trial location

Overseen By Stephanie C. DeMasi, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Under 18, Pregnant, Prisoner, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate (procedure duration)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of laryngoscope blade is most effective for intubating critically ill adults. The two blades being tested are a hyperangulated video laryngoscope blade and a standard geometry video laryngoscope blade. The primary objective is to identify which blade enables doctors to successfully insert a breathing tube on the first attempt, while also monitoring the patient's oxygen levels during the procedure. This trial involves critically ill patients who require a breathing tube and are in a participating hospital unit where a trained clinician will perform the procedure. As an unphased trial, it provides patients the opportunity to contribute to important research that could enhance intubation techniques for critically ill patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these laryngoscope blades are safe for critically ill adults?

Previous studies have shown that using video laryngoscopes, with either curved or straight blades, is now common for placing a tube into the windpipe in emergency and intensive care settings. Guidelines worldwide recommend these tools.

Research indicates that curved video laryngoscopes have a higher success rate on the first try for difficult cases, often helping doctors place the tube correctly on the first attempt. Safety checks have examined risks such as inhaling harmful substances, incorrect tube placement, and low oxygen levels.

The straight video laryngoscope is also widely used and has proven more effective than traditional tools for first-attempt success in critically ill patients. This suggests that both types are generally safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of two different types of video laryngoscope blades for critical illness. The hyperangulated video laryngoscope blade offers a unique angle that may improve the view of the vocal cords, potentially making intubation easier in challenging cases. On the other hand, the standard geometry video laryngoscope blade is well-established but might not offer the same enhanced visibility in difficult airways. This trial aims to determine whether the hyperangulated blade can provide a significant advantage over the standard option, potentially leading to better outcomes for patients requiring intubation.

What evidence suggests that this trial's laryngoscope blades could be effective for critical illness?

This trial will compare the effectiveness of two types of video laryngoscope blades. Research has shown that special curved video laryngoscope blades, like the hyperangulated blade used in one arm of this trial, can help doctors successfully insert a breathing tube on the first try, especially in patients with difficult airways. Some studies suggest these blades make the process easier and more effective, though results can vary among individuals. Conversely, the standard geometry video laryngoscope blade, used in another arm of this trial, also outperforms traditional direct laryngoscopes, increasing the chances of success on the first attempt. Both types of video laryngoscopes generally lead to better outcomes compared to older methods. Overall, both options have shown promise in improving success rates for inserting breathing tubes in critical situations. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

The ANGLE Trial is for critically ill adults who need a tube placed in their windpipe (tracheal intubation) and are being treated in emergency departments or intensive care units. Specific eligibility details aren't provided, but typically participants must meet certain health criteria to join.

Inclusion Criteria

Patient is located in a participating unit

I am scheduled for a procedure that involves inserting a tube into my windpipe using a special tool.

My procedure will be done by a clinician skilled in tracheal intubation.

Exclusion Criteria

Patient is known to be pregnant

Patient is known to be a prisoner

Operator has determined that use of a hyperangulated video laryngoscope blade or a standard geometry video laryngoscope blade is required or contraindicated for the optimal care of the patient either because of factors related to the patient (e.g., patient's upper airway anatomy requires a specific blade type) or the operator (e.g., treating clinicians lack sufficient comfort with one of the blade types)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tracheal intubation using either a hyperangulated or standard geometry video laryngoscope blade

Immediate (procedure duration)

1 visit (in-person)

Follow-up

Participants are monitored for successful intubation and complications such as hypoxemia and severe complications during intubation

2 minutes post-intubation

What Are the Treatments Tested in This Trial?

Interventions

• Hyperangulated video laryngoscope blade
• Standard geometry video laryngoscope blade

Trial Overview This trial compares two types of blades used during tracheal intubation: one with a hyperangulated design and another with standard geometry. Patients will be randomly assigned to either method to see which one has higher success on the first try without causing low oxygen levels.

How Is the Trial Designed?

Group I: Hyperangulated video laryngoscope blade Active Control 1 Intervention

For patients assigned to the hyperangulated video laryngoscope blade group, the operator will use a hyperangulated video laryngoscope blade on the first laryngoscopy attempt.

Group II: Standard Geometry Video Laryngoscope Blade Group Active Control 1 Intervention

For patients assigned to the standard geometry laryngoscope blade group, the operator will use a standard geometry video laryngoscope blade on the first laryngoscopy attempt.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12186028/

Hyperangulated videolaryngoscope for difficult airway ... Hyperangulated videolaryngoscopes possess a more sharply curved blade or blade tip, resulting in a higher first-attempt success rate among patients with ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S073567572500573X

Effect of hyperangulated videolaryngoscopy on first-attempt ... Existing studies offer mixed results, with some suggesting that hyperangulated blades may enhance intubation success, particularly in patients with challenging ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07223762

Hyperangulated Versus Standard Geometry Laryngoscope ... To determine the effect of use of a hyperangulated video laryngoscope blade versus a standard geometry video laryngoscope blade on the incidence ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381729/

the randomised multicentre INVIBLADE-ICU trial study protocol In the INTUBE subanalysis study, a hyperangulated blade was used in 25% of patients intubated with a videolaryngoscope, and the standard ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2301601

Video versus Direct Laryngoscopy for Tracheal Intubation ... The use of a video laryngoscope resulted in a higher incidence of successful intubation on the first attempt than the use of a direct laryngoscope.

6. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04727-9

Video versus direct laryngoscopy in critically ill patients: an ... Safety endpoints were (5) incidence of aspiration, (6) esophageal intubation, (7) cardiac arrest, (8) severe hypoxemia, (9) dental injury, and ( ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0007091223001988

Efficacy and adverse events profile of videolaryngoscopy in ... In a systematic review of nine randomised trials in critically ill patients, videolaryngoscopy did not improve first-pass intubation success rate even when the ...