NCT04046770

Innovative Device for Intravenous Administration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Escola Superior de Enfermagem de Coimbra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing involves a pre and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, also increasing the need for manipulation of the venous catheter). A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.

Conditions

• Safety Issues
• Medical Device

Interventions

Type	Name	Description
DEVICE	Drug administration and Flushing procedure using Double-Chamber Syringe	The new device will allow the professional to conduct all the procedure (assure the patency/enables the pre-flushing), drugs administration and flushing, using only one device.
DEVICE	Drug administration and Flushing procedure using Classic Syringe	To fully complete the intravenous drug administration with rigor, nurses should flush the catheter pre, post and inbetween drug administration. This implies the use of two or three syringes.

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-10-01
• Completion: 2020-11-01
• First posted: 2019-08-06
• Last updated: 2019-08-28