Clinical trial NCT05412108: Prospective Evaluation of Complications of MidLine Catheters in the ICU
Official title: Prospective Evaluation of Complications of MidLine Catheters in the ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catheter Complications
Keywords: Midline catheter
ICU Hospitalization
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the ICU for whom an indication for placement of a MidLine catheter is identified during their ICU stay

Brief summary: Midline catheters (MCs) are peripheral catheters inserted into a vein in the arm above the elbow crease, with the tip in the axillary vein. As such, they do not enter the central venous circulation and are therefore not considered central venous catheters.

The main complications associated with CM are accidental removal, leakage, subcutaneous diffusion and occlusion. Severe complications include deep vein thrombosis (DVT) and catheter-related bacteremia (CRB). There is very little data on the use of CMs in intensive care units (ICU).

Resuscitation patients are more likely to develop severe catheter-related complications such as deep vein thrombosis and catheter-related infections. While the use of CMs in patients appears to be associated with a low risk of complications, this may not be the case in resuscitation patients.

Investigator therefore proposes to conduct a prospective observational study to determine the frequency and type of complications associated with CMs when they are implanted and used in ICU. In addition, investigator will attempt to determine whether risk factors predictive of complications can be identified. In addition, this study will evaluate whether the use of CMs can reduce the duration of central venous catheter maintenance in the ICU and the risk of central venous catheter-related infections.


Eligibility criteria: Inclusion Criteria:

* ICU Hospitalization
* Indication for MidLine catheter placement during the stay

Exclusion Criteria:

* Minor or protected adult
* Pregnant woman
* Local contraindication to the placement of a CM

  * Local infection
  * Venous thrombosis
  * Existing arteriovenous fistula or vascular network to be protected for a fistula for chronic dialysis
  * Paralysis of the limb
* Need for administration of contraindicated solutions on the peripheral venous route:

  * Catecholamines: Noradrenaline, adrenaline (dose greater than 0.2µg/kg/min)
  * Total parenteral nutrition
  * Glucose solutions at a concentration \>20
  * Potassium at a concentration \>0.1mEq/ml
  * Vesicants
  * Fluids with pH \<5 or \>9

Primary outcomes:
measure: Describe the incidence of severe complications associated with the use of CMs in ICUs
timeFrame: From midline catheter placement to hospital discharge (up to 28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References: