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

NCT04952649 | Unknown

• 1 other identifier: PITCH
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pacemaker Dependence

Keywords

peripheral perfusion index; cardiac output; stroke volume

Outcome Measures

Primary Outcomes (3)

• Cardiac output

  Measurement of cardiac output by Flotrac ,the metric is L/min.

  During the study procedure

• stroke volume

  Measurement of stroke volume by Flotrac ,the metric is ml.

  During the study procedure

• Peripheral perfusion index

  Measurement of Peripheral perfusion index by masimo radical.

  During the study procedure

Study Arms (1)

pacemaker dependent patients after cardiac surgery

Pacemakers are widely used in cardiotomy patients, while it's common that the patients happen to be pacemaker dependent. When the doctor decides to set the heart rate of the pacemaker, we record the hemodynamic parameters and peripheral perfusion index from 70-80-90-100-110 bpm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pacemakers are widely used in post-cardiotomy patients, while it's common that some patients may be pacemaker dependent. We choose these patients who has been placed with temportary pacemaker during the cardic surgery

You may qualify if:

• age \>=18 years old;
• postcardiotomy
• placement of temportary pacemaker during the surgery
• dependence of pacemaker (abscence of autonomic cardiac rhythm）

You may not qualify if:

• hemodynamic unstable （high dose of vasoactive drugs）
• fingers ischemia, cannot monitor the peripheral perfusion index

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (2)

• 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 Dec 1;56(6):933-938. doi: 10.1097/SHK.0000000000001811.

  PMID: 34014888 BACKGROUND

• 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. 2024 Sep-Oct;74(5):744169. doi: 10.1016/j.bjane.2021.04.030. Epub 2021 May 12.

  PMID: 33991553 BACKGROUND

Study Officials

• Zhe Luo, MD PhD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Guo-wei Tu, MD PhD

CONTACT

13501996995; tu.guowei@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 7, 2021
• Study Start: July 7, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

CN (1)