Pacemaker DependenceNCT04952649
The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker
An observational study of Pacemaker Dependence, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Dependence
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- age >=18 years old;
- postcardiotomy
- placement of temportary pacemaker during the surgery
- dependence of pacemaker (abscence of autonomic cardiac rhythm）
Who cannot join
- hemodynamic unstable （high dose of vasoactive drugs）
- fingers ischemia, cannot monitor the peripheral perfusion index
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Guo-wei Tu, Doctor, 86-13501996995, tu.guowei@zs-hospital.sh.cn
About this study
Official title: The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker：a Prospective Study
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.
Read the detailed 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.
- Conditions
- Pacemaker Dependence
- Keywords
- peripheral perfusion index, cardiac output, stroke volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Measurement of cardiac output by Flotrac ,the metric is L/min.
Measured: During the study procedure
stroke volume
Measurement of stroke volume by Flotrac ,the metric is ml.
Measured: During the study procedure
Peripheral perfusion index
Measurement of Peripheral perfusion index by masimo radical.
Measured: During the study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start7 Jul 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pacemaker DependenceStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Luo, MD PhD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952649
- Sponsor's protocol ID
- PITCH
- Status last verified
- Jul 2021
- First submitted
- 18 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34014888Abdel-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.
PubMed 33991553
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker：a Prospective Study
- ClinicalTrials.gov ID
- NCT04952649
- Acronym / sponsor ID
- PITCH
- Conditions
- Pacemaker Dependence
- Keywords
- peripheral perfusion index, cardiac output, stroke volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- age >=18 years old;
- postcardiotomy
- placement of temportary pacemaker during the surgery
- dependence of pacemaker (abscence of autonomic cardiac rhythm）
Key exclusion criteria (2 listed)
- hemodynamic unstable （high dose of vasoactive drugs）
- fingers ischemia, cannot monitor the peripheral perfusion index
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac output
Time frame: During the study procedure
Measurement of cardiac output by Flotrac ,the metric is L/min.
stroke volume
Time frame: During the study procedure
Measurement of stroke volume by Flotrac ,the metric is ml.
Peripheral perfusion index
Time frame: During the study procedure
Measurement of Peripheral perfusion index by masimo radical.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Background: PubMed 34014888Bazaraa 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.
- Background: PubMed 33991553Abdel-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhe Luo, MD PhD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker Dependence, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo-wei Tu, MD PhD (13501996995, tu.guowei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: During the study procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04952649, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.