Evaluating the effects of high flow nasal oxygen therapy during deep sedation
What is the Effect of Deep Procedural Sedation With HFNOT on the tcPCO2, mitoPO2 and mitoVO2.
This study is testing whether high flow nasal oxygen therapy can help keep patients safe and breathing well during deep sedation for medical procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06124027 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of high flow nasal oxygen therapy (HFNOT) on patients undergoing deep procedural sedation. It focuses on monitoring key parameters such as tcPCO2, mitoPO2, and mitoVO2 to assess ventilation adequacy during sedation. The study aims to understand the balance between sedation depth and respiratory function, particularly in patients who may be at risk for inadequate ventilation. By analyzing these parameters, the research seeks to enhance patient safety during procedures requiring deep sedation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years scheduled for procedures requiring deep procedural sedation with high flow nasal oxygen therapy.
Not a fit: Patients with conditions such as porphyria, mitochondrial disease, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient safety and outcomes during procedures that require deep sedation by ensuring adequate ventilation.
How similar studies have performed: While the use of HFNOT during sedation is gaining attention, this specific approach to monitoring ventilation parameters is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years * Acceptable proficiency of the Dutch language * Scheduled for a procedure requiring deep procedural sedation with HFNOT. Exclusion Criteria: * Porphyria * Known intolerance to components of the ALA plaster * Presence of mitochondrial disease * Pregnancy/lactation * Patients with skin lesions on the measurement location which impede measurements * Incapability to provide inform consent, due to a mental condition interfering with the ability to understand the provided information
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Calvin de Wijs, MSc
- Email: c.dewijs@erasmusmc.nl
- Phone: 0107032804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.