Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04366947
Other study ID # IO_PPE_1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 14, 2020
Est. completion date October 30, 2020

Study information

Verified date December 2020
Source Lazarski University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 30, 2020
Est. primary completion date September 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Out-of-hospital cardiac arrest (OHCA) - Adult = 18 years old - Non-traumatic cause of cardiac arrest Exclusion Criteria: - Existing do-not-attempt-resuscitation order - OHCA patients with contraindications to IO access or IV access - Patients with signs of obvious death, e.g. rigor mortis

Study Design


Intervention

Device:
NIO® (Intraosseous access)
obtaining intravascular access using a ready intravenous NIO needle set
Standard of Care (Intravenous access)
obtaining intravascular access using a standard intravenous cannula

Locations

Country Name City State
Poland Lazarsku University Warsaw Masovian

Sponsors (4)

Lead Sponsor Collaborator
Lazarski University Medical University of Bialystok, Poznan University of Medical Sciences, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate of first intravascular access attempt successful placement of intravascular device 1 day
Secondary time to successful access time to successful access 1 day
Secondary number of attempts to successful access number of attempts to successful access 1 day
Secondary time to infusion time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics 1 day
Secondary complication rates complication rates 1 day
Secondary ROSC the rate of survival to hospital admission 1 day
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05898126 - Renin-guided Hemodynamic Management in Patients With Shock N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT05066256 - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock N/A
Not yet recruiting NCT06285513 - Cardiovascular Metabolic Remodeling in Shock
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Terminated NCT02755155 - Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients Phase 4
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A
Terminated NCT01696175 - PICU Admission Lactate and Central Venous Oxymetry Study N/A
Recruiting NCT01157299 - Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO N/A
Recruiting NCT01174966 - Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients N/A
Completed NCT00743522 - Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication
Completed NCT03296891 - Point of Care Ultrasonography In The Management of Shock: A Pilot Study N/A
Recruiting NCT05922982 - Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery N/A
Withdrawn NCT04705701 - Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care N/A
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT05330676 - Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT04089098 - VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility
Completed NCT03190408 - Variation in Fluids Administered in Shock