NCT05512117

Brief Summary

The study aims to evaluate the rate of complications and the duration of cannulation of a midline intravenous catheter compared to a short peripheral catheter in patients hospitalized in an Internal Medicine service of a Spanish hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 18, 2022

Last Update Submit

August 20, 2022

Conditions

Keywords

phlebitis

Outcome Measures

Primary Outcomes (3)

  • Length of canalization

    Days of catheter stay

    Four weeks

  • Number of punctures

    Number of times a catheter is inserted

    Four weeks

  • Phlebitis

    Presence of catheter related phlebitis

    Four weeks

Study Arms (2)

Midline Catheter

EXPERIMENTAL

Midline catheter insertion

Device: Midline insertion

Peripheral intravenous cannulation (PIVC)

NO INTERVENTION

Peripheral intravenous cannulation (PIVC)

Interventions

Midline catheter insertion

Midline Catheter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients included were those who were hospitalized in the Internal Medicine Service of the Consorcio Hospital General Universitario de Valencia who needed intravenous therapy and who had signed the Informed Consent for placement of a midline at the time of the change of the PIVC placed in the emergency unit.

You may not qualify if:

  • Those with a forecast hospitalization of less than one week, those who were receiving palliative or symptomatic treatment, those who were carriers of a CVC or those who had presented difficulty in venous access with midline after two consecutive attempts were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Related Publications (13)

  • Millington SJ, Hendin A, Shiloh AL, Koenig S. Better With Ultrasound: Peripheral Intravenous Catheter Insertion. Chest. 2020 Feb;157(2):369-375. doi: 10.1016/j.chest.2019.04.139. Epub 2019 Oct 22.

    PMID: 31654617BACKGROUND
  • Prasanna N, Yamane D, Haridasa N, Davison D, Sparks A, Hawkins K. Safety and efficacy of vasopressor administration through midline catheters. J Crit Care. 2021 Feb;61:1-4. doi: 10.1016/j.jcrc.2020.09.024. Epub 2020 Oct 2.

    PMID: 33049486BACKGROUND
  • Nickel B. Does the Midline Peripheral Intravenous Catheter Have a Place in Critical Care? Crit Care Nurse. 2021 Dec 1;41(6):e1-e21. doi: 10.4037/ccn2021818.

    PMID: 34851379BACKGROUND
  • Moureau N, Chopra V. Indications for peripheral, midline and central catheters: summary of the MAGIC recommendations. Br J Nurs. 2016 Apr 28-May 11;25(8):S15-24. doi: 10.12968/bjon.2016.25.8.S15.

    PMID: 27126759BACKGROUND
  • Skaggs MKD, Daniels JF, Hodge AJ, DeCamp VL. Using the Evidence-Based Practice Service Nursing Bundle to Increase Patient Satisfaction. J Emerg Nurs. 2018 Jan;44(1):37-45. doi: 10.1016/j.jen.2017.10.011. Epub 2017 Nov 20.

    PMID: 29167032BACKGROUND
  • Mohn-Brown E. Implementing Quality and Safety Education for Nurses in Postclinical Conferences: Transforming the Design of Clinical Nursing Education. Nurse Educ. 2017 Sep/Oct;42(5S Suppl 1):S18-S21. doi: 10.1097/NNE.0000000000000410.

    PMID: 28832457BACKGROUND
  • Johansen H, Helgesen AK. Palliative care in the community - the role of the resource nurse, a qualitative study. BMC Palliat Care. 2021 Oct 14;20(1):157. doi: 10.1186/s12904-021-00860-w.

    PMID: 34645424BACKGROUND
  • Selby LM, Rupp ME, Cawcutt KA. Prevention of Central-Line Associated Bloodstream Infections: 2021 Update. Infect Dis Clin North Am. 2021 Dec;35(4):841-856. doi: 10.1016/j.idc.2021.07.004.

    PMID: 34752222BACKGROUND
  • Panepinto R, Harris J, Wellette J. A Review of Best Practices Related to Intravenous Line Management for Nurses. Nurs Clin North Am. 2021 Sep;56(3):389-399. doi: 10.1016/j.cnur.2021.05.001.

    PMID: 34366159BACKGROUND
  • Timsit JF, Baleine J, Bernard L, Calvino-Gunther S, Darmon M, Dellamonica J, Desruennes E, Leone M, Lepape A, Leroy O, Lucet JC, Merchaoui Z, Mimoz O, Misset B, Parienti JJ, Quenot JP, Roch A, Schmidt M, Slama M, Souweine B, Zahar JR, Zingg W, Bodet-Contentin L, Maxime V. Expert consensus-based clinical practice guidelines management of intravascular catheters in the intensive care unit. Ann Intensive Care. 2020 Sep 7;10(1):118. doi: 10.1186/s13613-020-00713-4.

    PMID: 32894389BACKGROUND
  • Farina J, Cornistein W, Balasini C, Chuluyan J, Blanco M. [Central venous catheter related infections. Inter-Societies update and recommendations]. Medicina (B Aires). 2019;79(1):53-60. Spanish.

    PMID: 30694189BACKGROUND
  • Scoppettuolo G, Pittiruti M, Pitoni S, Dolcetti L, Emoli A, Mitidieri A, Migliorini I, Annetta MG. Ultrasound-guided "short" midline catheters for difficult venous access in the emergency department: a retrospective analysis. Int J Emerg Med. 2016 Dec;9(1):3. doi: 10.1186/s12245-016-0100-0. Epub 2016 Feb 4.

    PMID: 26847572BACKGROUND
  • Villalba-Nicolau M, Chover-Sierra E, Saus-Ortega C, Ballestar-Tarin ML, Chover-Sierra P, Martinez-Sabater A. Usefulness of Midline Catheters versus Peripheral Venous Catheters in an Inpatient Unit: A Pilot Randomized Clinical Trial. Nurs Rep. 2022 Oct 31;12(4):814-823. doi: 10.3390/nursrep12040079.

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesVasculitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Neither care providers nor patients could be masked because the intravenous device is different and it's easy to identify the one we are using. Outcomes assessor only works with anonymized data
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Intravenous access catheter in control group is conventional intravenous catheter (Braun Introcan Safety) Intravenous access catheter in intervention group is a midline catheter 12 cm length (Leader Cath 20 G. Vygon)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 23, 2022

Study Start

February 1, 2017

Primary Completion

April 1, 2017

Study Completion

September 30, 2017

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations