Sedation ComplicationNCT06124027
Impact of Sedation With HFNOT on tcPCO2, mitoPO2 and mitoVO2.
An observational study of Sedation Complication and High Flow Nasal Oxygen Therapy, run by Calvin de Wijs, MSc at 1 site in Netherlands.
Trial summary
Deep procedural sedation has seen an increased use indication over the last couple of years aided by the introduction of high flow nasal oxygen therapy (HFNOT) during these procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation Complication, High Flow Nasal Oxygen Therapy
- What is being tested?
- Monitoring tcPCO2 and mitoPO2
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Feb 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed of patients undergoing procedures which require deep procedural sedation with HFNOT.
Who may be able to join
- Age over 18 years
- Acceptable proficiency of the Dutch language
- Scheduled for a procedure requiring deep procedural sedation with HFNOT.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GD
Calvin de Wijs, MSc, 0107032804, c.dewijs@erasmusmc.nl
About this study
Official title: What is the Effect of Deep Procedural Sedation With HFNOT on the tcPCO2, mitoPO2 and mitoVO2.
Deep procedural sedation has seen an increased use indication over the last couple of years aided by the introduction of high flow nasal oxygen therapy (HFNOT) during these procedures. However, this level of deep sedation does come with the increased risk of examining whether a patient is adequately ventilated during this procedure.
The definition of deep sedation is: 'a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.' As the definition showed there may be an insufficient ventilation during deep sedation. Therefore, HFNOT is used to ensures that the peripheral oxygen saturation is sufficient. However, there are two potential disadvantages. HFNOT can mask the presence of an insufficient respiratory minute volume and an insufficient gas exchange, which can lead to high arterial CO2 (paCO2) levels. Another risk associated with HFNOT is the fact that high oxygen levels are toxic, and prolonged exposure to high partial oxygen pressures, can cause oxidative damage to cell membranes, collapse of the alveoli in the lungs, retinal detachment, and seizures. Most of this damage can be explained by hyperoxia that increases the 'leak' of electrons from the mitochondrial electron transport chain and the resulting increased generation of reactive oxygen species (ROS). Low paCO2 levels and hyperoxia cannot be examined using standard monitoring techniques therefore, this study will use the transcutaneous carbon dioxide (tcPCO2) a proven technique which correlates well to the arterial CO2 (paCO2) to evaluate whether there is an adequate level of ventilation during deep procedural anesthesia with HFNOT. Moreover, the cutaneous mitochondrial oxygenation (mitoPO2) will be monitored to determine the effects that deep procedural sedation with HFNOT has on the cellular oxygenation.
- Being tested
- Monitoring tcPCO2 and mitoPO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring tcPCO2 and mitoPO2Device
Monitoring tcPCO2 using SenTec and mitoPO2 using COMET
What is being measured
The primary outcome is the main question the study is designed to answer.
tcPCO2.
To examine the effects of deep procedural sedation and use of HFNOT on the tcPCO2.
Measured: up to 6 hours
mitoPO2
To determine the effects of deep procedural sedation and use of HFNOT on the mitoPO2
Measured: up to 6 hours
Secondary outcomes (1)
mitoVO2
To determine the effects of deep procedural sedation and use of HFNOT on the mitoVO2
Measured: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start13 Feb 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calvin de Wijs, MSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Calvin de Wijs, MSc, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124027
- Sponsor's protocol ID
- MEC-2022-0421
- Other IDs
- NL81086.078.22
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of Deep Procedural Sedation With HFNOT on the tcPCO2, mitoPO2 and mitoVO2.
- ClinicalTrials.gov ID
- NCT06124027
- Acronym / sponsor ID
- MEC-2022-0421
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Calvin de Wijs, MScUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deep procedural sedation has seen an increased use indication over the last couple of years aided by the introduction of high flow nasal oxygen therapy (HFNOT) during these procedures. However, this level of deep sedation does come with the increased risk of examining whether a patient is adequately ventilated during this procedure.
The definition of deep sedation is: 'a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.' As the definition showed there may be an insufficient ventilation during deep sedation. Therefore, HFNOT is used to ensures that the peripheral oxygen saturation is sufficient. However, there are two potential disadvantages. HFNOT can mask the presence of an insufficient respiratory minute volume and an insufficient gas exchange, which can lead to high arterial CO2 (paCO2) levels. Another risk associated with HFNOT is the fact that high oxygen levels are toxic, and prolonged exposure to high partial oxygen pressures, can cause oxidative damage to cell membranes, collapse of the alveoli in the lungs, retinal detachment, and seizures. Most of this damage can be explained by hyperoxia that increases the 'leak' of electrons from the mitochondrial electron transport chain and the resulting increased generation of reactive oxygen species (ROS). Low paCO2 levels and hyperoxia cannot be examined using standard monitoring techniques therefore, this study will use the transcutaneous carbon dioxide (tcPCO2) a proven technique which correlates well to the arterial CO2 (paCO2) to evaluate whether there is an adequate level of ventilation during deep procedural anesthesia with HFNOT. Moreover, the cutaneous mitochondrial oxygenation (mitoPO2) will be monitored to determine the effects that deep procedural sedation with HFNOT has on the cellular oxygenation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of patients undergoing procedures which require deep procedural sedation with HFNOT.
Key inclusion criteria (3 listed)
- Age over 18 years
- Acceptable proficiency of the Dutch language
- Scheduled for a procedure requiring deep procedural sedation with HFNOT.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring tcPCO2 and mitoPO2Monitoring tcPCO2 using SenTec and mitoPO2 using COMET | Device | – |
Primary outcome
tcPCO2.
Time frame: up to 6 hours
To examine the effects of deep procedural sedation and use of HFNOT on the tcPCO2.
mitoPO2
Time frame: up to 6 hours
To determine the effects of deep procedural sedation and use of HFNOT on the mitoPO2
1 secondary outcome
mitoVO2
Time frame: up to 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation Complication and High Flow Nasal Oxygen Therapy, run by Calvin de Wijs, MSc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Calvin de Wijs, MSc (0107032804, c.dewijs@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tcPCO2. (time frame: up to 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.