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Procedure

Intervention group for Airway Management (OPTIMISE-2 Trial)

N/A

Recruiting

Research Sponsored by Insel Gruppe AG, University Hospital Bern

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical indications.

Neonates and infants up to 52 weeks postconceptual age, with legal guardians providing written informed consent before the intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

OPTIMISE-2 Trial Summary

This trial wants to find out the best amount of oxygen needed during a procedure called tracheal intubation. They will be using a special device called the C-MAC video laryngoscope

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, potential risks may include irritation from the nasal cannula, discomfort from the high or low flow of oxygen, and general risks associated with tracheal intubation.

OPTIMISE-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

OPTIMISE-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

First attempt success rate

Secondary outcome measures

Cormack-Lehane score

Duration of severe desaturation

First EtCO2 after successful intubation

+7 more

OPTIMISE-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 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 groupActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Royal Perth HospitalOTHER

17 Previous Clinical Trials

6,421 Total Patients Enrolled

Insel Gruppe AG, University Hospital BernLead Sponsor

774 Previous Clinical Trials

1,809,853 Total Patients Enrolled

2 Trials studying Airway Management

460 Patients Enrolled for Airway Management

University Hospital, GenevaOTHER

493 Previous Clinical Trials

1,858,188 Total Patients Enrolled

1 Trials studying Airway Management

210 Patients Enrolled for Airway Management

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"According to the information available on clinicaltrials.gov, this study is currently actively seeking participants. The initial posting of the study occurred on December 1st, 2023, and the most recent update was made on January 26th, 2024."

Answered by AI

What is the current number of subjects participating in this investigation?

"Indeed, the data available on clinicaltrials.gov indicates that this trial is actively seeking participants. The trial was initially posted on December 1st, 2023 and last updated on January 26th, 2024. In total, the study aims to enroll a cohort of 1192 patients from six different sites."

Answered by AI

In how many medical facilities is this examination being conducted?

"This trial is being conducted at six specific sites, namely the Department of Anesthesia at Montreal Children's Hospital and McGill University Health Centre in Montréal, Deutsches Herzzentrum der Charité and Charité in Berlin, as well as the Department of Cardiac Anesthesiology and Intensive Care Medicine at Charité Universitätsmedizin in Bern. Additionally, there are six other locations where this trial is also taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)

2023. "Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05967507.