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New treatment option for Anesthesia
Official title Apnoeic Oxygenation During Pediatric Tracheal Intubation
ClinicalTrials.gov ID: NCT06576596
What this study is testing
- What it's testing
- The goal of this randomized, controlled, single-blinded clinical trial is to evaluate the effectiveness of apnoeic Oxygenation in pediatric anesthesia. The main question it aims to answer are: primary outcome measure: The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 6
You may be able to join if
- children 0-6 years
- ASA status I-III
- Elective surgery/intervention under general anaesthesia
You likely can't join if
- refusal to participate in the study by the patients or their legal guardians
- ASA classification IV = patients with life-threatening disease
- Existing oxygen therapy prior to surgery
- Surgery/intervention in the ENT area with contraindication for oxygen goggles
- Injuries/trauma in the ENT and mouth/nose area
- Anatomical anomalies/malformations in the ENT and mouth/nose area
See the full eligibility criteria
- children 0-6 years
- ASA status I-III
- Elective surgery/intervention under general anaesthesia
- refusal to participate in the study by the patients or their legal guardians
- ASA classification IV = patients with life-threatening disease
- Existing oxygen therapy prior to surgery
- Surgery/intervention in the ENT area with contraindication for oxygen goggles
- Injuries/trauma in the ENT and mouth/nose area
- Anatomical anomalies/malformations in the ENT and mouth/nose area
- Chronical hypoxemia (e.g. patients with cyanotic heart diseases)
- language barrier (parent/guardian)
- emergency interventions
- refusal by the attending physician
- lack of presence of the pediatric anesthesiology consultant
- Situational inability to perform apnoeic oxygenation or inability to obtain baseline NIRS values at room air within 60 seconds from the first attempt due to agitation of the patient
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Wurttemberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.