Supplemental Oxygen for Airway Management

(OPTIMISE-2 Trial)

Recruiting at 6 trial locations

Overseen By Thomas Riva, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Riva

Disqualifiers: Difficult intubation, Congenital heart disease, Cardiopulmonary collapse, others

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

Compensation: Varies

Number of Visits: 2

1192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the optimal oxygen flow rate for young patients undergoing tracheal intubation, a procedure to assist breathing. Researchers aim to determine if a significant difference exists between low-flow and high-flow oxygen during this procedure. The trial compares two groups: one using low-flow nasal supplemental oxygen and the other using high-flow nasal supplemental oxygen. It seeks newborns and infants up to 52 weeks old who require intubation for planned or semi-urgent surgeries. As an unphased trial, this study provides a unique opportunity for patients to contribute to important research that could enhance future medical procedures.

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 this method is safe for airway management?

Research has shown that both low-flow and high-flow oxygen are generally safe during the insertion of a breathing tube. One study found that high-flow oxygen maintained better oxygen levels than low-flow oxygen in some situations. Despite this, low-flow oxygen remains widely used and is usually well-tolerated. Another study found that low-flow oxygen sometimes resulted in lower oxygen levels after tube insertion, but serious side effects were rare.

Overall, medical settings safely use both methods. While low-flow oxygen might not boost oxygen levels as effectively as high-flow oxygen, it remains a safe choice for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different approaches to delivering supplemental oxygen during tracheal intubation, which is crucial for maintaining patient safety. The intervention group uses a low-flow nasal supplemental oxygen method, providing 0.2 L/kg/min FiO2 1.0, which could offer a gentler alternative to high-flow systems. On the other hand, the control group uses high-flow nasal supplemental oxygen at 2 L/kg/min FiO2 1.0, a more common practice. This trial aims to assess whether the low-flow method is as effective as the high-flow approach, potentially leading to more tailored oxygen delivery strategies during airway management.

What evidence suggests that this trial's treatments could be effective for airway management?

Research has shown that high-flow nasal oxygen (HFNO) helps maintain better oxygen levels during tracheal intubation. In this trial, participants in the control group will receive high-flow nasal supplemental oxygen. Studies have linked this to higher minimum oxygen levels, indicating generally better oxygen levels for patients. Conversely, participants in the intervention group will receive low-flow nasal supplemental oxygen, which has been associated with lower oxygen levels in some cases. For example, one study found that after intubation, only 12.9% of patients using high-flow oxygen experienced low oxygen levels, compared to 57.1% of those using low-flow oxygen. This evidence suggests that high-flow oxygen may be more effective at maintaining stable oxygen levels during intubation. ^{6 7 8 9 10}

Who Is on the Research Team?

Thomas Riva, MD

Principal Investigator

University of Bern

Are You a Good Fit for This Trial?

This trial is for neonates and infants up to 52 weeks postconceptual age who need oral or nasal tracheal intubation for various medical procedures. Legal guardians must consent. It's not suitable for those outside this age range or without guardian consent.

Inclusion Criteria

My child needs a breathing tube for a planned or urgent procedure.

My child is under 52 weeks old and I can provide consent for them.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation and Induction

Eligible children are prepared for intubation according to local SOPs, including pre-oxygenation and administration of anesthesia and neuromuscular blocking agents.

1 day

1 visit (in-person)

Intubation Procedure

Tracheal intubation is performed with randomized low-flow or high-flow supplemental oxygen using the C-MAC video laryngoscope.

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for respiratory complications and other outcomes within the first 24 hours post-intubation.

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• High-flow nasal supplemental oxygen
• Laryngoscopy
• Low-flow nasal supplemental oxygen
• Tracheal Intubation

Trial Overview

The study compares high-flow versus low-flow supplemental oxygen during tracheal intubation using a C-MAC video laryngoscope in young patients. The goal is to find the best oxygen flow rate needed during this procedure.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

0.2 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with the C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.

Group II: Control group Active Control 1 Intervention

2 L/kg/min FiO2 1.0 high-flow nasal supplemental oxygen with the Optiflow (Fisher \& Paykel Healthcare, Auckland, New Zealand) during tracheal intubation performed with the C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.

Laryngoscopy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Laryngoscopy for:

• Airway management
• Endotracheal tube placement
• Anesthesia support

Approved in United States as Laryngoscopy for:

• Airway management
• Endotracheal tube placement
• Anesthesia support

Approved in Canada as Laryngoscopy for:

• Airway management
• Endotracheal tube placement
• Anesthesia support

Approved in Japan as Laryngoscopy for:

• Airway management
• Endotracheal tube placement
• Anesthesia support

Approved in China as Laryngoscopy for:

• Airway management
• Endotracheal tube placement
• Anesthesia support

Approved in Switzerland as Laryngoscopy for:

• Airway management
• Endotracheal tube placement
• Anesthesia support

Who Is Running the Clinical Trial?

Thomas Riva

Lead Sponsor

Trials

4

Recruited

109,000+

Insel Gruppe AG, University Hospital Bern

Lead Sponsor

Trials

831

Recruited

2,353,000+

Istituto Giannina Gaslini

Collaborator

Trials

47

Recruited

140,000+

Royal Perth Hospital

Collaborator

Trials

19

Recruited

11,000+

University Hospital, Geneva

Collaborator

Trials

522

Recruited

1,868,000+

Centre Hospitalier Universitaire Vaudois

Collaborator

Trials

269

Recruited

14,040,000+

Luzerner Kantonsspital

Collaborator

Trials

90

Recruited

326,000+

Charite University, Berlin, Germany

Collaborator

Trials

1,071

Recruited

3,739,000+

Gaslini Children's Hospital

Collaborator

Trials

7

Recruited

107,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

In a study of 67 awake patients undergoing flexible bronchoscopy, it was found that routine oxygen supplementation is not necessary for the procedure, as only 50.7% of patients required it.

The baseline oxygen saturation level was a key predictor for the need for supplemental oxygen, with all patients needing it having a baseline saturation of 92% or lower, highlighting the importance of monitoring oxygen levels before the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen supplementation during awake fibreoptic bronchoscopy in a Nigerian tertiary hospital. Onakpoya, UU., Adewole, O., Ogunrombi, AB., et al.[2013]

Apnoeic oxygenation during tracheal intubation in children significantly increases the first-pass success rate without causing physiological instability, as shown in a systematic review of 15 studies involving 9802 children.

This technique also helps maintain higher oxygen saturation levels and reduces the incidence of hypoxaemia, indicating its effectiveness in improving safety during intubation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apnoeic oxygenation during paediatric tracheal intubation: a systematic review and meta-analysis. Fuchs, A., Koepp, G., Huber, M., et al.[2023]

In a study involving 250 neonates and infants, video laryngoscopy was found to significantly improve the first-attempt tracheal intubation success rate (89.3%) compared to direct laryngoscopy (78.9%) when both techniques were used with supplemental oxygen.

The incidence of adverse events was similar between the two groups, indicating that video laryngoscopy is a safe alternative and should be considered the preferred method for intubating neonates and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct versus video laryngoscopy with standard blades for neonatal and infant tracheal intubation with supplemental oxygen: a multicentre, non-inferiority, randomised controlled trial. Riva, T., Engelhardt, T., Basciani, R., et al.[2023]

Videolaryngoscopy significantly improves patient outcomes in airway management compared to direct laryngoscopy, leading to better first-pass success in tracheal intubation and reduced complications such as difficult laryngeal views and airway trauma.

Despite its advantages and recommendations for routine use in clinical practice, videolaryngoscopy is not widely adopted due to barriers like perceived costs, inadequate training, and concerns about diminishing skills in direct laryngoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway Management: The Current Role of Videolaryngoscopy. Saul, SA., Ward, PA., McNarry, AF.[2023]

Airway management is crucial for ensuring oxygenation, and if one method (like facemask or intubation) fails, having alternative techniques ready can prevent hypoxia and other complications.

Differentiating between failed laryngoscopy and failed intubation is essential, as the strategies to address these failures differ, and anesthesiologists must be prepared to perform emergency surgical airways when necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation for and Management of "Failed" Laryngoscopy and/or Intubation. Cooper, RM.[2020]

A training course using fresh frozen cadavers (FFC) allowed trauma surgeons, regardless of their prior experience, to achieve a first pass success rate (FPSR) of 100% when using a combination of videolaryngoscopy, bougie, and positioning techniques, demonstrating the effectiveness of these methods in emergency airway management.

The study showed that the airway characteristics of the FFC model closely matched those of real pre-hospital patients treated by helicopter emergency medical services (HEMS), making it a valuable tool for training and skill maintenance in tracheal intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-creating reality: validation of fresh frozen full cadaver airway training with videolaryngoscopy and bougie FIRST strategy : The BOAH-course: a prospective, observational study. Imach, S., Kölbel, B., Böhmer, A., et al.[2022]

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]

In a study of 54 critically ill patients, the first-attempt success rate for endotracheal intubation was similar between the video-guided intubation (96%) and direct laryngoscopy (93%), indicating no significant advantage for the video technique in this context.

Both methods showed comparable safety profiles, with no incidents of vomiting, aspiration, or accidental esophageal intubation, suggesting that both techniques are safe for use in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endotracheal tube-mounted camera-assisted intubation versus conventional intubation in intensive care: a prospective, randomised trial (VivaITN). Grensemann, J., Eichler, L., Wang, N., et al.[2019]

The McGrath MAC video laryngoscope significantly reduced the duration of laryngoscopy compared to both the Truview and Macintosh laryngoscopes, making the intubation process quicker and potentially safer.

Both the McGrath MAC and Truview video laryngoscopes showed better ease of intubation and fewer optimization maneuvers needed compared to the Macintosh laryngoscope, with no trauma reported in the McGrath MAC group, highlighting its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of McGrath MAC, Truview Video Laryngoscopes and Macintosh Laryngoscope for Endotracheal Intubation in Patients Undergoing Surgery under General Anaesthesia. Kaur, G., Gupta, S., Mehta, N., et al.[2022]

In a study of 1,341 anesthetized infants, 16% experienced multiple laryngoscopy attempts during routine tracheal intubation, which significantly increased the risk of hypoxemia (35% incidence).

While multiple laryngoscopy attempts were linked to hypoxemia, they did not show a significant association with bradycardia, indicating that repeated attempts may primarily affect oxygen levels rather than heart rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoxemia, Bradycardia, and Multiple Laryngoscopy Attempts during Anesthetic Induction in Infants: A Single-center, Retrospective Study. Gálvez, JA., Acquah, S., Ahumada, L., et al.[2020]

In a study of 2916 critically ill patients, videolaryngoscopy led to a higher first-pass intubation success rate (84%) compared to direct laryngoscopy (79%), indicating it may be a more effective method for intubation in this high-risk population.

Despite being used in patients with a higher likelihood of difficult airways, videolaryngoscopy did not increase the risk of major adverse events, suggesting it is a safe option for intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. Russotto, V., Lascarrou, JB., Tassistro, E., et al.[2023]

In a study of 86 controlled hypertensive patients undergoing general anesthesia, both oral clonidine and intravenous lidocaine were found to be equally effective in attenuating hemodynamic responses during laryngoscopy and tracheal intubation, with no significant differences in heart rate or blood pressure between the two groups.

However, the clonidine group experienced significantly higher rates of side effects, including mouth dryness, bradycardia, and orthostatic hypotension, indicating that while both drugs are effective, clonidine may carry more risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Clonidine and Lidocaine on Attenuation of Hemodynamic Responses to Laryngoscopy and Tracheal Intubation in Controlled Hypertensive Patients: A Randomized, Double-Blinded Clinical Trial. Soltani Mohammadi, S., Maziar, A., Saliminia, A.[2022]

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