HFNC vs LFNC in Patients With AF Undergoing RFCA Under Deep Sedation.

April 8, 2024 updated by: Maastricht University Medical Center

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229HX
        • Recruiting
        • Maastricht UMC
        • Contact:
        • Contact:
          • Esther AC Bouman, Dr.
          • Phone Number: 5606 0031433876543

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults undergoing an elective RFCA for atrial fibrillation in the Maastricht UMC Cardiac Catheter Labs under deep sedation administered by a clinician anesthesiology

Exclusion Criteria:

  • 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
  • Active nose bleeding
  • Untreated pneumothorax (pre- existing)
  • Recent upper airway surgery
  • Recent base of skull fracture
  • Expected difficult airway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High flow nasal cannula
Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen during deep sedation.
Device: High flow nasal cannula
HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.
Other Names:
  • High flow nasal oxygen
No Intervention: Low flow nasal cannula
Participants in the current standard of care will receive low flow nasal cannula during deep sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The outcome variable will be measured during the patient's sedation (0-4 hours).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hypoxemia event
Time Frame: The outcome variable will be measured during the patient's sedation (0-4 hours).
The secondary outcome measure will be the duration of the lowest measured blood oxygen level during the patient's sedation.
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).
The secondary outcome measure will be cross over from oxygen therapy during sedation yes/no.
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).
The secondary outcome measure will be the incidence SpO2 under 90% for > 60 seconds.
The outcome variable will be measured during the patient's sedation (0-4 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Esther AC Bouman, Doctor, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 72859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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