The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker

Pacemaker Dependence Clinical Trial

Official title:

The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker：a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952649
• Other study ID #: PITCH
• Status: Recruiting
• Start date: July 7, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Guo-wei Tu, MD PhD
• Phone: 13501996995
• Email: tu.guowei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. The peripheral perfusion index (PI) has been considered as an effective parameter evaluating the circulation. In this study, investigators aim to avaluate the ability of peripheral perfusion index to detect changes of hemodynamics in postcardiotomy patients with pacemakers.

Description:

Pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. The peripheral perfusion index (PI) has been considered as an effective parameter evaluating the circulation. In this study, investigators aim to evaluate the ability of peripheral perfusion index to detect changes of hemodynamics (cardiac output or storke volume,et al) in postcardiotomy patients with pacemakers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >=18 years old;

• postcardiotomy

• placement of temportary pacemaker during the surgery

• dependence of pacemaker (abscence of autonomic cardiac rhythm)

Exclusion Criteria:

• hemodynamic unstable (high dose of vasoactive drugs)

• fingers ischemia, cannot monitor the peripheral perfusion index

Related Conditions & MeSH terms

• Pacemaker Dependence

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. Using the perfusion index to predict changes in the depth of anesthesia in children compared with the A-line Autoregression Index: an observational study. Braz J Anesthesiol. 2021 May 12. pii: S0104-0014(21)00198-6. doi: 10.1016/j.bjane.2021.04.030. [Epub ahead of print] — View Citation

Bazaraa H, Roby S, Salah E, Algebaly H. Assessment of Tissue Perfusion Using the Peripheral Perfusion Index and Lactate Clearance in Shock in Pediatric Patients. Shock. 2021 May 19. doi: 10.1097/SHK.0000000000001811. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	Measurement of cardiac output by Flotrac ,the metric is L/min.	During the study procedure
Primary	stroke volume	Measurement of stroke volume by Flotrac ,the metric is ml.	During the study procedure
Primary	Peripheral perfusion index	Measurement of Peripheral perfusion index by masimo radical.	During the study procedure