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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05513482
Other study ID # 2022/449352
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 23, 2022
Est. completion date April 1, 2024

Study information

Verified date January 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact Deniz Mutlu, MD
Phone +902124143000
Email deniz.mutlu92@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 1, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
M Mode Imaging
Diaphragm displacement during inspiration and expiration will be measured with M mode imaging

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Cammarota G, Boniolo E, Santangelo E, De Vita N, Verdina F, Crudo S, Sguazzotti I, Perucca R, Messina A, Zanoni M, Azzolina D, Navalesi P, Longhini F, Vetrugno L, Bignami E, Della Corte F, Tarquini R, De Robertis E, Vaschetto R. Diaphragmatic Kinetics Ass — View Citation

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder I — View Citation

Soilemezi E, Savvidou S, Sotiriou P, Smyrniotis D, Tsagourias M, Matamis D. Tissue Doppler Imaging of the Diaphragm in Healthy Subjects and Critically Ill Patients. Am J Respir Crit Care Med. 2020 Oct 1;202(7):1005-1012. doi: 10.1164/rccm.201912-2341OC. — View Citation

Tokuda M, Yamashita S, Sato H, Oseto H, Ikewaki H, Yokoyama M, Isogai R, Tokutake KI, Yokoyama KI, Kato M, Narui R, Tanigawa SI, Matsuo S, Yoshimura M, Yamane T. Long-term course of phrenic nerve injury after cryoballoon ablation of atrial fibrillation. S — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure 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 The effect of subclinical diaphragm damage on morbidity 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
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