Ultrasonography Evaluation of Diaphragm Kinetics in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon

August 23, 2022 updated by: Deniz Mutlu, Istanbul University - Cerrahpasa (IUC)

Prospective Evaluation of Diaphragm Kinetics With Tissue Doppler Imaging in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon

The purpose of this study to assess the diaphragm kinetics with Tissue Doppler Imaging in patients undergoing atrial fibrillation ablation with cryoballoon

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed to evaluate the diaphragm kinetics with ultrasonography parameters in patients who underwent pulmonary vein isolation (PVI) for atrial fibrillation (AF) by Cryoballoon. Due to the proximity of the pulmonary veins to the phrenic nerve, phrenic nerve paralysis can be seen rarely during the procedure. In contemporary practice, phrenic nerve damage is detected by visual monitoring of diaphragm movement as a result of pacing with high output by placing the intracardiac stimulation catheter at the level of the superior vena cava. However, subclinical nerve damage may be critical regarding respiratory functions, especially in patients with comorbidities. It has been shown in the literature that the evaluation of diaphragm kinetics with Tissue Doppler Imaging (TDI) can be used in effective ventilation monitoring and weaning. However, this technique has not been used in patients who have previously undergone cryoballoon therapy. It is aimed to investigate the positive or negative effects on diaphragm kinetics, as a very cost-effective and rapidly accessible technique, with the help of this technique.

Study Type

Observational

Enrollment (Anticipated)

80

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

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

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study population will consist of patients who are planned for AF ablation with the cryobaloon, whose preoperative ultrasonography can be interpreted and who gave their consent.

Description

Inclusion Criteria:

  • Patients scheduled for AF ablation with a cryoballoon
  • ≥18 years old
  • Patients with interpretable diaphragm ultrasound before the operation
  • Patients giving informed consent

Exclusion Criteria:

  • Patients who did not give consent
  • Patients with phrenic nerve palsy
  • Morbid obesity

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cryoballoon pulmonary vein isolation for atrial fibrillation ablation
Diaphragmatic kinetics of participants before and after pulmonary vein isolation will be evaluated with the Tissue Doppler and M Mode Imaging.
Diagnostic test: Tissue Doppler Imaging
With tissue Doppler ultrasonography (TDI), the maximum contraction rate of the diaphragm, maximum relaxation rate, and integral against time will be examined.
Other Names:
  • GE Vivid T8 Ultrasonography System
Diagnostic test: M Mode Imaging
Diaphragm displacement during inspiration and expiration will be measured with M mode imaging
Other Names:
  • GE Vivid T8 Ultrasonography System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure
Time Frame: Preoperative baseline and postoperative first hour
Unlike the traditional method, diaphragm Tissue Doppler imaging (TDI) will be used to diagnose phrenic nerve injury in patients during cryoballoon ablation. This method aims to detect the damages that may have occurred even though no visible damage has occurred. The peak contraction velocity (PCV) that has been found to be effective on weaning success will be used in TDI. The literature shows that the PCV measured by TDI in healthy humans is 1.32 ⨦ 0.39 cm/sec. Based on this, the patient's baseline and post-procedure PCVs will be compared.
Preoperative baseline and postoperative first hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of subclinical diaphragm damage on morbidity
Time Frame: Preoperative baseline and postoperative 24 hours
Side effects that may occur as a consequence of these will be observed in patients with subclinical diaphragm injury.
Preoperative baseline and postoperative 24 hours

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Chair: Kivanc Yalin, Assoc Prof., Istanbul University - Cerrahpasa (IUC)

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 (Anticipated)

August 30, 2022

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/449352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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