Assessment of Effectiveness of Continuous Non-invasive Haemodynamic Monitor by Compared to Invasive Blood Pressure and Pulse Oximeter Monitoring on Patients Undergoing General Anesthesia Surgeries for More Than 60 Minutes

Assessment of the Effectiveness of the Continuous Non-invasive Haemodynamic Monitor

The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter monitoring.

Researchers will compare blood pressure data derived from MOH200 to the invasive blood pressure (IBP) data to see if the MOH200 is effective to measure the blood pressure of a surgical person. Also, researchers will compare pulse rate data drived from MOH200 to that from the pulse oximeter to see if the MOH200 is effective to measure the pulse rate of a surgical person.

Participants will be asked to be applied with MOH200 monitoring while IBP monitoring and pulse oximeter are applied. And after 30 minutes of the surgery, researchers will monitor the adverse effects occurred on the skin of participants to assess the safety of MOH200.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure; General Anesthesia; Arterial Line; Pulse Rate

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Zhiqiang Zhou; Phone Number: +86-13886043314; Email: 328667192@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients are going to undergoing a general anesthetic surgery for more than 60 minutes at the site (Tongji Hospital, Tongji Medical College of HUST) who are accord with the inclusion criteria and do not satisfy the exclusion criteria.

Description

Inclusion Criteria:

1. Patients undergoing general anesthesia surgeries for more than 60 minutes with IBP monitoring
2. Patients aging between 4 to 80 years old (including at least 5 pediatric subjects between 4 to 12 years old, and as for subjects over 12 years old, up to 60% of subjects between 12 to 50 years old, at least 15% of subjects between 50 to 60 years old, at least 15% of subjects between 60 to 70 years old, and at least 10% of subjects over 70 years old)
3. At least 30% of subjects is male and 30% is female
4. Volunteer to participate the study and sign the informed consent form willingly

Exclusion Criteria:

1. Patients with severe heart diseases which affect the stability of haemodynamics
2. Patients applied with the heart-lung machine, defibrillator or cardiopulmonary bypass
3. Patients with coagulation disorders, vasculopathy or vascular prostheses
4. Patients with cutaneous diseases, infections or trauma of the measured part of the body leading to failure of data acquisition
5. Patients with mental diseases, epilepsy or other diseases leading to involuntrary movements of the body
6. Patients with BMI no more than 17 or no less than 30 kg/m^2
7. Patients who are pregnant or at the unstable stage of diseases or with severe shock
8. Patients with infections or trauma at the position of artery cannulation, whose pulse is untouchable or who get positive in the Allen's test
9. Patients with diseases that the investigators think unsuitable for participating the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Non -invasive Blood Pressure Measurement from MOH200	The blood pressure is measured by MOH200 and recorded on the CRF for every 5 minutes, including mean blood pressure, diastolic blood pressure and systolic blood pressure.	During the surgery
Invasive Blood Pressure Measurement from Arterial Line	The blood pressure is synchronously measured by the radial arterial line and also recorded on the CRF for every 5 minutes, including mean arterial pressure, diastolic blood pressure and systolic blood pressure.	During the surgery
Pulse Rate Measurement from MOH200	The pulse rate is measured by the MOH200 and recorded on the CRF for every 5 minutes.	During the surgery
Pulse Rate Measurement from Pulse Oximeter	The pulse rate is measured by the pulse oximeter and recorded on the CRF for every 5 minutes during the surgery.	During the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Occurrence of Pressure Pores	In order to evaluate the safety of the haemodynamic monitor MOH200, the occurrence of device-related pressure pores is recorded. The incidence of adverse reactions=(the number of pressure sore occurrence/the total number of subjects observed)×100%	Once after all the subjects are recruited and the clinical trials are finished

Collaborators and Investigators

• Sponsor: BLZ Technology (Wuhan) Co.,Ltd
• Investigators: Principal Investigator: Zhiqiang Zhou, Department of Anesthesiology, Tongji Hospital, Tongji Medical College of HUST

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BLZ2024MOH

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