Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

NCT ID: NCT05411315

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2023-07-14

Brief Summary

Investigators will conduct a pragmatic randomized trial to investigate the non-inferiority of restricted use of invasive arterial lines compared to standard arterial line use.

Detailed Description

Patients in the medical intensive care unit (MICU) often receive arterial lines as standard of care, however there are little data to support this practice. Investigators will randomly assign consecutive weeks to either current practice(control) or to a more conservative practice of not placing invasive arterial lines except for limited indication indications as defined below (intervention). Patients entering during an intervention week will be treated according to the intervention practice throughout their ICU stay. Likewise, patients entering during a control week will be treated according to current standard practice.

Permuted block randomization will be used to assure equal numbers of intervention and control weeks. All outcome measures will be obtained through EPIC data analytics and post-hospitalization phone calls. Weekly randomization codes will be generated by the study statisticians and delivered to MICU staff via sealed envelopes to be opened at the beginning of each week.

Conditions

Mechanical Ventilation Complication; Arterial Thrombosis; Limb Ischemia; Shock; Hypotension; Bloodstream Infection; Vasopressor Adverse Reaction; Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Restricted-use of arterial catheters

Group Type: EXPERIMENTAL

Restricted-use of arterial catheter

Intervention Type: OTHER

The investigator will restrict the use of arterial catheters unless exclusion criteria is met.

Standard-use of arterial catheters

Group Type: ACTIVE_COMPARATOR

Standard-use of arterial catheter

Intervention Type: OTHER

The investigator will allow standard-use of arterial catheters

Interventions

Restricted-use of arterial catheter

The investigator will restrict the use of arterial catheters unless exclusion criteria is met.

Intervention Type: OTHER

Standard-use of arterial catheter

The investigator will allow standard-use of arterial catheters

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All subjects admitted to the medical intensive care unit

Exclusion Criterion:

• All subjects <18 years of age.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David J. Feller-Kopman

Professor of Medicine, Geisel School of Medicine Chief, Pulmonary and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Feller-Kopman, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

STUDY02001496

Identifier Type: -

Identifier Source: org_study_id