An Exploratory Study of Perioperative Venous Access in Obese Patients

Sponsor

Sir Run Run Shaw Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06031545

Collaborator

(none)

528

Enrollment

Location

Arms

Anticipated Duration (Months)

21.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Catheter Complications	Other: Long peripheral venous catheters for use Other: Midline catheter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

528 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Not possible because of the material and characteristics of the catheter

Primary Purpose:

Other

Official Title:

An Exploratory Study of Perioperative Venous Access in Obese Patients

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Catheter-related complication rate [during catheter indwelling,an average of 2 weeks]
The proportion of patients with complications as a proportion of the total number of cases

Secondary Outcome Measures

Catheter retention days [during catheter indwelling,an average of 2 weeks]
Number of days from the day of catheter placement to the day of extubation
Completion rate of treatment via one catheter [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linfang Zhao	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Sir Run Run Shaw Hospital

Investigators

Principal Investigator: Linfang Zhao, Sir Run Run Shaw Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Sir Run Run Shaw Hospital

ClinicalTrials.gov Identifier:

NCT06031545

Other Study ID Numbers:

20230718072255619

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 11, 2023