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Search / Trial NCT06124027

Impact of Sedation With HFNOT on tcPCO2, mitoPO2 and mitoVO2.

Launched by CALVIN DE WIJS, MSC · Nov 3, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of deep sedation combined with high flow nasal oxygen therapy (HFNOT) during medical procedures. Deep sedation makes patients less aware of their surroundings, which can help during certain treatments, but it can also make it harder for them to breathe on their own. The trial aims to find out if using a special method to monitor carbon dioxide levels in the body can help ensure that patients are breathing adequately while under deep sedation with HFNOT. Researchers will also check how well oxygen is being used at the cellular level during this process.

To participate in this study, you must be an adult over 18 years old, speak Dutch well enough to understand the information provided, and be scheduled for a procedure that requires deep sedation with HFNOT. However, individuals with certain conditions, such as specific genetic disorders or those who are pregnant, cannot participate. If you join the study, you can expect to have your breathing and oxygen levels monitored in a way that helps keep you safe during your procedure. This trial is a way to improve patient safety and care during sedation.

Gender

ALL

Eligibility 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

About Calvin De Wijs, Msc

Calvin de Wijs, MSc, is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and innovation. With a background in biomedical sciences and extensive experience in clinical study design and oversight, he plays a pivotal role in ensuring the integrity and compliance of clinical trials. Calvin's focus on patient safety and ethical standards drives his approach to facilitating the development of new therapies and interventions aimed at improving health outcomes. His leadership fosters collaboration among researchers, healthcare professionals, and regulatory bodies, contributing to the successful execution of trials that adhere to the highest scientific and ethical standards.

Locations

Rotterdam, Zuid Holland, Netherlands

Rotterdam, South Holland, Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported