Deep SedationNCT04842253
HFNC Vs LFNC in Patients with AF Undergoing RFCA Under Deep Sedation.
A study testing High flow nasal cannula in people with Deep Sedation and Oxygen Therapy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Oxygen supplementation through high flow nasal cannula (HFNC) may reduce the incidence of desaturation and hypoxemia during deep sedation at radiofrequency catheter ablation (RFCA procedures).This study is designed to test the hypothesis that the incidence of hypoxemia and desaturation in patients with atrial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Sedation, Oxygen Therapy, Radiofrequency Ablation
- What is being tested?
- High flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Jan 2022to 18 Nov 2024
- Phase
- Interventional
- 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
Who may be able to join
- Adults undergoing an elective RFCA for atrial fibrillation in the Maastricht UMC Cardiac Catheter Labs under deep sedation administered by a clinician anesthesiology
Who cannot join
- Age under 18 years
- Body Mass Index (BMI) > 32 kg/m²
- Diagnosed Sleep Apnoea Syndrome (SAS)
- Chronic Pulmonary Obstructive Disease (COPD) gold IV and COPD gold III with frequent or recent exacerbation
- Diagnosed pulmonary or cardiac condition requiring chronic oxygen therapy
- Complete nasal obstruction
Show all 11Show fewer
- Active nose bleeding
- Untreated pneumothorax (pre- existing)
- Recent upper airway surgery
- Recent base of skull fracture
- Expected difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Nasal Cannula (HFNC) Versus Standard Low Flow Nasal Cannula (LFNC) in Patients with Atrial Fibrillation Undergoing Radiofrequency Catheter Ablation (RFCA) Under Deep Desaturation.
Oxygen supplementation through high flow nasal cannula (HFNC) may reduce the incidence of desaturation and hypoxemia during deep sedation at radiofrequency catheter ablation (RFCA procedures).This study is designed to test the hypothesis that the incidence of hypoxemia and desaturation in patients with atrial fibrillation undergoing RFCA under deep sedation, is less when using HFNC as compared to use of standard low flow nasal cannula (LFNC).
Read the detailed description
Desaturation may occur in patients under deep sedation which results in an elevated risk for perioperative adverse events including hypoxemia (1-3). The incidence of hypoxemia was 168 per 1000 in a general procedural sedation and analgesia population (4). The clinical significance of transient episodes of hypoxemia remains debatable. However, many peri-operative incidents are often short-term and limited in nature, but a number of them are a predictor to a serious complication with a permanent injury (5).This study investigates if high flow nasal cannula (HFNC) as compared to low flow nasal cannula (LFNC) will result in a lower incidence of intra-procedural oxygen desaturation and hypoxemia in patients with atrial fibrillation undergoing deep sedation for radiofrequency catheter ablation (RFCA).
- Conditions
- Deep Sedation, Oxygen Therapy, Radiofrequency Ablation
- Being tested
- High flow nasal cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
Also called High flow nasal oxygen
HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula | Experimental | Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen during deep sedation. Receives: Device: High flow nasal cannula |
| Low flow nasal cannula | No intervention | Participants in the current standard of care will receive low flow nasal cannula during deep sedation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia event
The primary outcome measure will be the lowest measured blood oxygen level during the patient's sedation.
Measured: The outcome variable will be measured during the patient's sedation (0-4 hours).
Secondary outcomes (3)
Duration of hypoxemia event
The secondary outcome measure will be the duration of the lowest measured blood oxygen level during the patient's sedation.
Measured: The outcome variable will be measured during the patient's sedation (0-4 hours).
Cross over from oxygen therapy
The secondary outcome measure will be cross over from oxygen therapy during sedation yes/no.
Measured: The outcome variable will be measured during the patient's sedation (0-4 hours).
To measure the incidence of hypoxemia and desaturation (SpO2 under 90% for > 60 seconds).
The secondary outcome measure will be the incidence SpO2 under 90% for > 60 seconds.
Measured: The outcome variable will be measured during the patient's sedation (0-4 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start4 Jan 2022
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Why it stopped: Due to changes in logistics (indications Rf and attendance PFA), it has not been feasible to include the required number of participants in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Deep SedationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther AC Bouman, Doctor, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842253
- Sponsor's protocol ID
- 72859
- Status last verified
- Feb 2025
- First submitted
- 8 Apr 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share IPD is still undecided because we are not certain if we are going to share all collected IPD or all IPD that underlie results in a publication.
Publications
Jirapinyo P, Thompson CC. Sedation Challenges: Obesity and Sleep Apnea. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):527-37. doi: 10.1016/j.giec.2016.03.001.
PubMed 27372775Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.
PubMed 19003534Salukhe TV, Willems S, Drewitz I, Steven D, Hoffmann BA, Heitmann K, Rostock T. Propofol sedation administered by cardiologists without assisted ventilation for long cardiac interventions: an assessment of 1000 consecutive patients undergoing atrial fibrillation ablation. Europace. 2012 Mar;14(3):325-30. doi: 10.1093/europace/eur328. Epub 2011 Oct 23.
PubMed 22024600Conway A, Sutherland J. Depth of anaesthesia monitoring during procedural sedation and analgesia: A systematic review and meta-analysis. Int J Nurs Stud. 2016 Nov;63:201-212. doi: 10.1016/j.ijnurstu.2016.05.004. Epub 2016 May 25.
PubMed 27236824Koers L, Eberl S, Cappon A, Bouwman A, Schlack W, Hermanides J, Preckel B. Safety of moderate-to-deep sedation performed by sedation practitioners: A national prospective observational study. Eur J Anaesthesiol. 2018 Sep;35(9):659-666. doi: 10.1097/EJA.0000000000000835.
PubMed 29847362Sago T, Watanabe K, Kawabata K, Shiiba S, Maki K, Watanabe S. A Nasal High-Flow System Prevents Upper Airway Obstruction and Hypoxia in Pediatric Dental Patients Under Intravenous Sedation. J Oral Maxillofac Surg. 2021 Mar;79(3):539-545. doi: 10.1016/j.joms.2020.10.018. Epub 2020 Oct 16.
PubMed 33176129Homberg MC, Bouman EA, Linz D, van Kuijk SMJ, Joosten BA, Buhre WF. High-flow nasal cannula versus standard low-flow nasal cannula during deep sedation in patients undergoing radiofrequency atrial fibrillation catheter ablation: a single-centre randomised controlled trial. Trials. 2022 May 9;23(1):378. doi: 10.1186/s13063-022-06362-1.
PubMed 35534903
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula (HFNC) Versus Standard Low Flow Nasal Cannula (LFNC) in Patients with Atrial Fibrillation Undergoing Radiofrequency Catheter Ablation (RFCA) Under Deep Desaturation.
- ClinicalTrials.gov ID
- NCT04842253
- Acronym / sponsor ID
- 72859
- Conditions
- Deep Sedation, Oxygen Therapy, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to changes in logistics (indications Rf and attendance PFA), it has not been feasible to include the required number of participants in this study
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 13 Apr 2021 (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.
Oxygen supplementation through high flow nasal cannula (HFNC) may reduce the incidence of desaturation and hypoxemia during deep sedation at radiofrequency catheter ablation (RFCA procedures).This study is designed to test the hypothesis that the incidence of hypoxemia and desaturation in patients with atrial fibrillation undergoing RFCA under deep sedation, is less when using HFNC as compared to use of standard low flow nasal cannula (LFNC).
Detailed description
Desaturation may occur in patients under deep sedation which results in an elevated risk for perioperative adverse events including hypoxemia (1-3). The incidence of hypoxemia was 168 per 1000 in a general procedural sedation and analgesia population (4). The clinical significance of transient episodes of hypoxemia remains debatable. However, many peri-operative incidents are often short-term and limited in nature, but a number of them are a predictor to a serious complication with a permanent injury (5).This study investigates if high flow nasal cannula (HFNC) as compared to low flow nasal cannula (LFNC) will result in a lower incidence of intra-procedural oxygen desaturation and hypoxemia in patients with atrial fibrillation undergoing deep sedation for radiofrequency catheter ablation (RFCA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula | Experimental | Device: High flow nasal cannulaParticipants in the high flow nasal cannula group will receive high flow nasal cannula oxygen during deep sedation. |
| Low flow nasal cannula | No intervention | –Participants in the current standard of care will receive low flow nasal cannula during deep sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing an elective RFCA for atrial fibrillation in the Maastricht UMC Cardiac Catheter Labs under deep sedation administered by a clinician anesthesiology
Key exclusion criteria (11 listed)
- Age under 18 years
- Body Mass Index (BMI) > 32 kg/m²
- Diagnosed Sleep Apnoea Syndrome (SAS)
- Chronic Pulmonary Obstructive Disease (COPD) gold IV and COPD gold III with frequent or recent exacerbation
- Diagnosed pulmonary or cardiac condition requiring chronic oxygen therapy
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 |
|---|---|---|
| High flow nasal cannulaAlso: High flow nasal oxygenHFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation. | Device | High flow nasal cannula |
Primary outcome
Hypoxemia event
Time frame: The outcome variable will be measured during the patient's sedation (0-4 hours).
The primary outcome measure will be the lowest measured blood oxygen level during the patient's sedation.
3 secondary outcomes
Duration of hypoxemia event
Time frame: The outcome variable will be measured during the patient's sedation (0-4 hours).
Cross over from oxygen therapy
Time frame: The outcome variable will be measured during the patient's sedation (0-4 hours).
To measure the incidence of hypoxemia and desaturation (SpO2 under 90% for > 60 seconds).
Time frame: The outcome variable will be measured during the patient's sedation (0-4 hours).
Results and safety
The study was stopped early (reason given: Due to changes in logistics (indications Rf and attendance PFA), it has not been feasible to include the required number of participants in this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 27372775Jirapinyo P, Thompson CC. Sedation Challenges: Obesity and Sleep Apnea. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):527-37. doi: 10.1016/j.giec.2016.03.001.
- Background: PubMed 19003534Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.
- Background: PubMed 22024600Salukhe TV, Willems S, Drewitz I, Steven D, Hoffmann BA, Heitmann K, Rostock T. Propofol sedation administered by cardiologists without assisted ventilation for long cardiac interventions: an assessment of 1000 consecutive patients undergoing atrial fibrillation ablation. Europace. 2012 Mar;14(3):325-30. doi: 10.1093/europace/eur328. Epub 2011 Oct 23.
- Background: PubMed 27236824Conway A, Sutherland J. Depth of anaesthesia monitoring during procedural sedation and analgesia: A systematic review and meta-analysis. Int J Nurs Stud. 2016 Nov;63:201-212. doi: 10.1016/j.ijnurstu.2016.05.004. Epub 2016 May 25.
- Background: PubMed 29847362Koers L, Eberl S, Cappon A, Bouwman A, Schlack W, Hermanides J, Preckel B. Safety of moderate-to-deep sedation performed by sedation practitioners: A national prospective observational study. Eur J Anaesthesiol. 2018 Sep;35(9):659-666. doi: 10.1097/EJA.0000000000000835.
- Background: PubMed 33176129Sago T, Watanabe K, Kawabata K, Shiiba S, Maki K, Watanabe S. A Nasal High-Flow System Prevents Upper Airway Obstruction and Hypoxia in Pediatric Dental Patients Under Intravenous Sedation. J Oral Maxillofac Surg. 2021 Mar;79(3):539-545. doi: 10.1016/j.joms.2020.10.018. Epub 2020 Oct 16.
- Derived from this study: PubMed 35534903Homberg MC, Bouman EA, Linz D, van Kuijk SMJ, Joosten BA, Buhre WF. High-flow nasal cannula versus standard low-flow nasal cannula during deep sedation in patients undergoing radiofrequency atrial fibrillation catheter ablation: a single-centre randomised controlled trial. Trials. 2022 May 9;23(1):378. doi: 10.1186/s13063-022-06362-1.
- Individual participant dataSharing planned: Undecided. The plan to share IPD is still undecided because we are not certain if we are going to share all collected IPD or all IPD that underlie results in a publication.
Related trials for Deep Sedation
Recruiting
A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Recruiting
Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Mental Function
Not yet recruitingPhase 4
Remimazolam Concentration and Sedation Depth During Lower Extremity Surgery Under Spinal Anesthesia
Sedation During Lower Extremity Surgery Under Spinal Anesthesia
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
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.
Esther AC Bouman, Doctor principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula in people with Deep Sedation and Oxygen Therapy, run by Maastricht University Medical Center 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 1 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Feb 2025. 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?
The study was stopped early (reason given: Due to changes in logistics (indications Rf and attendance PFA), it has not been feasible to include the required number of participants in this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia event (time frame: The outcome variable will be measured during the patient's sedation (0-4 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04842253, which also lists 7 linked publications.
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 20 Feb 2025.