Innovative Device for Intravenous Administration

NCT04046770 | Unknown DMC

• 1 other identifier: SeringaDuo
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

safety; Effectiveness; Double-chamber syringe; Clinical research; medical devices; nurses; hospital setting

Outcome Measures

Primary Outcomes (3)

• Catheter-related complications: phlebitis

  Phlebitis (the irritation or inflammation to the vein wall, associated with warmth, tenderness, erythema or palpable cord) is the most frequent PIVC-related complication, which may have mechanical, chemical, or bacterial causes

  This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and 48 hours to 72 hours after catheter removal.

• Catheter-related complications: infiltration

  Moreover, the extravasation or infiltration of fluids may be responsible for local oedema due to the pervasion of intravenous fluid into the interstitial compartment, causing inflammation of the tissue around the catheter site.

  This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).

• Catheter-related complications: occlusion

  Occlusion is defined as any circumstance in which the Peripheral Intravenous Catheter (PIVC) does not enable to flush the catheter or infuse fluids/medications and it is a clinical sign of catheter malfunctioning

  This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).

Secondary Outcomes (1)

• Other catheter-related removal causes not related with the primary outcomes

  This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and in 48 hours to 72 hours after catheter removal.

Study Arms (2)

Double-Chamber Syringe

EXPERIMENTAL

Intravenous administration of drugs and flushing with the Double-Chamber Syringe

Device: Drug administration and Flushing procedure using Double-Chamber Syringe

Classical Syringes

ACTIVE COMPARATOR

Intravenous administration of drugs and flushing with the classical syringe

Device: Drug administration and Flushing procedure using Classic Syringe

Interventions

Drug administration and Flushing procedure using Double-Chamber Syringe DEVICE

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.

Double-Chamber Syringe

Drug administration and Flushing procedure using Classic Syringe DEVICE

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.

Classical Syringes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 18 years or above, admitted to the orthopaedic department;
• Patients with the ability to fully communicate in Portuguese;
• Patients able to consent;
• Prescribed PIVC for intravenous therapeutic administration;
• PIVC expected to remain for at least 24 hours;
• PIVC inserted at the orthopaedic department;
• PIVC size 18 gauge (G) or 20 G;
• Anatomical insertion site in arm, forearm, or back of the hand;
• PIVC secured with a transparent, semi-permeable polyurethane film dressing.

You may not qualify if:

• \- Patients with a known infectious disease;
• Patients with leucocytosis, defined as ≥1200 leukocytes/mm3;
• Patients with anaemia, with haemoglobin levels \<13g/dl for men, and \<12g/dl for women;
• Patients receiving immunosuppressive treatment within 6 months prior to hospital admission;
• Patients receiving chemotherapy or radiotherapy within 6 months prior to hospital admission;
• Patients with body mass index below 16 kg/m2 or above 39 kg/m2;
• Anatomical insertion site in flexion areas (e.g. cubital fossa region) or lower members;
• Skin lesions at the insertion site (e.g. previous infiltration, dermatitis, burns) and skin alterations such as tattoos;
• Peripheral venous alterations resulting from previous hospital admissions.

Sponsors & Collaborators

• Escola Superior de Enfermagem de Coimbra: lead
• Hospital de Braga: collaborator
• Unidade Local de Saúde de Coimbra, EPE: collaborator
• Hospital Distrital da Figueira da Foz, EPE: collaborator

Related Publications (26)

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• Parreira P, Sousa LB, Marques IA, Santos-Costa P, Braga LM, Cruz A, Salgueiro-Oliveira A. Double-chamber syringe versus classic syringes for peripheral intravenous drug administration and catheter flushing: a study protocol for a randomised controlled trial. Trials. 2020 Jan 14;21(1):78. doi: 10.1186/s13063-019-3887-1.

  PMID: 31937342 DERIVED

Study Officials

• Pedro Parreira, PhD

  Coordinating Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Parreira, PhD

CONTACT

+351 239802850 / 239487200; parreira@esenfc.pt

Anabela Salgueiro-Oliveira, PhD

CONTACT

+351 239802850 / 239487200; anabela@esenfc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients and clinical staff will not be entirely blind after group allocation due to the nature of the interventions. Despite this, participants will not be directly informed of their group allocation in terms of usual care or intervention, and the nurses in the clinical staff will only be informed about the broad purposes of the research \[41\] - the study of a new double-chamber syringe for intravenous administration and flushing. In contrast, research nurses from the team outside the orthopaedic department will be blinded when rating some of the main outcomes such as phlebitis and infiltration.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, Coordinating Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 6, 2019
• Study Start: July 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share