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

NCT06383000 | Not Yet Recruiting

• 1 other identifier: BLZ2024MOH
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

General Anesthesia; Blood Pressure; Pulse Rate; Arterial Line

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• The Occurrence of Pressure Pores

  Once after all the subjects are recruited and the clinical trials are finished

Eligibility Criteria

• Age: 4 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing general anesthesia surgeries for more than 60 minutes with IBP monitoring
• 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)
• At least 30% of subjects is male and 30% is female
• Volunteer to participate the study and sign the informed consent form willingly

You may not qualify if:

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

Sponsors & Collaborators

• BLZ Technology (Wuhan) Co.,Ltd: lead

Study Officials

• Zhiqiang Zhou

  Department of Anesthesiology, Tongji Hospital, Tongji Medical College of HUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiqiang Zhou

CONTACT

+86-13886043314; 328667192@qq.com

Study Design

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

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share