An Exploratory Study of Perioperative Venous Access in Obese Patients

September 4, 2023 updated by: Sir Run Run Shaw Hospital
This study is intended to explore the application effect of long peripheral intravenous catheters(LPCs) and midline catheters(MCs) in the perioperative period of obese patients, aiming at providing the scientific basis for the optimal perioperative venous access for the obese patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is intended to explore the application effect of long peripheral intravenous catheters(LPCs) and midline catheters(MCs) in the perioperative period of obese patients; at the same time, the LPCs will be used as the control group and the MCs as the experimental group, to compare whether the application of LPCs in the perioperative period of obese patients is not inferior to that of the MCs; the comprehensive comparison of the effect of the clinical application and the evaluation of the health economics, aiming at providing the scientific basis for the optimal perioperative venous access for the obese patients.

Study Type

Interventional

Enrollment (Estimated)

528

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Linfang Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Obese patients (BMI ≥ 30kg/m2) who are to undergo surgery.
  • Expected length of hospitalisation within 2 weeks.
  • Conscious and able to communicate normally.

Exclusion Criteria:

  • It is expected that perioperative medications will need to be infused via a central venous catheter (e.g. total parenteral nutrition TPN);
  • Patients with an indwelling central venous catheter on admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long peripheral venous catheters
In the test group used LPCs during the perioperative period in obese patients
Other: Long peripheral venous catheters for use
Long peripheral venous catheters for use during the perioperative period in obese patients
Other: Midline catheters
In the control group used LPCs during the perioperative period in obese patients
Other: Midline catheter
Midline catheters for use during the perioperative period in obese patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter-related complication rate
Time Frame: during catheter indwelling,an average of 2 weeks
The proportion of patients with complications as a proportion of the total number of cases
during catheter indwelling,an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter retention days
Time Frame: during catheter indwelling,an average of 2 weeks
Number of days from the day of catheter placement to the day of extubation
during catheter indwelling,an average of 2 weeks
Completion rate of treatment via one catheter
Time Frame: during catheter indwelling,an average of 2 weeks
Number of patient cases in which all infusion treatments were completed via one catheter/total number of patient cases
during catheter indwelling,an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Investigators

  • Principal Investigator: Linfang Zhao, Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20230718072255619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

You can email if you need to

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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