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A clinical trial to study the effects of two different practices of peripheral IV catheter insertion on incidence of local site infections / inflammation

A Randomized Control Trial to Compare the Incidence of Thrombophlebitis related to CDC Recommended Peripheral Intravascular Cannula Insertion Practices with a Standard Cleaning Protocol followed during Cannula Insertion - PIVC

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011104
Enrollment
200
Registered
2018-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients listed for elective surgical operations in operation theatres of hospital

Interventions

Intervention1: Group B - STANDARD SURGICAL CLEANING: Group B: A standard defined cleaning steps and procedure during insertion will be followed for 50 patients which is defined as follows : i.) Ide

Sponsors

Armed Forces Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.) One hundred patients in whom intravenous catheter insertion be carried out by the researcher himself will be included in the study. They will be followed up till catheter removal OR up till 72 hours of catheter insertion whichever is earlier. 2.) Only patients with ASA Status I, II & III undergoing elective surgery will be enrolled. 3.) To remove study bias arising due to gender only male volunteers will be recruited in the study. 4.) Individuals with age between 20 years to 60 years will be included in the study. 5.) Individuals with cannula inserted in upper extremities only will be included in the study.

Exclusion criteria

Exclusion criteria: 1.) ASA Status IV, V and those requiring emergency surgery/ intervention. 2.) Patients enlisted for day care surgery or on OPD based anesthetic requirement. 3.) Immunocompromised patients. 4.) Patients on any chemotherapy for malignancy. 5.) Patients diagnosed as sepsis syndrome. 6.) Patients in whom I.V. catheters were indicated for less than 24 hours. 7.) Patients requiring blood transfusions from same cannulas. 8.) If more than 2 attempts are taken at insertion.

Design outcomes

Primary

MeasureTime frame
During withdrawal, the duration for which the cannula remained in situ will be calculated along with the condition of the patient and presence of any signs of thrombophlebitis.Timepoint: Max 72 hours observation or at time of catheter removal, whichever is earlier. During withdrawal, the duration for which the cannula remained in situ will be calculated along with the condition of the patient and presence of any signs of thrombophlebitis.

Secondary

MeasureTime frame
Other Points noted will be the number of attempts taken at insertion, site of insertion, guage of catheter used and the type of procedure followed during insertion.Timepoint: maximum 72 hours or at time of catheter removal, whichever is earlier. Other Points noted will be the number of attempts taken at insertion, site of insertion, guage of catheter used and the type of procedure followed during insertion.

Countries

India

Contacts

Public ContactASHUTOSH GUPTA

AFMC , Pune

drashutoshgupta@yahoo.co.in7770073152

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026