Recruiting

POCUS

Sponsor:

London Health Sciences Centre

Code:

NCT04180553

Conditions

Aortic Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Point of Care Ultrasound (POCUS)

Usual Care

Study Details

Brief summary:

This study will aim to determine whether routine Point of Care Ultrasound (POCUS) assessment of volume status, cardiac function, and pulmonary function after major abdominal aortic surgery is an accurate and feasible form of monitoring for individualized, goal-directed resuscitation. Half of the patients will receive POCUS-guided fluid resuscitation, and the other half will be resuscitated using usual post-operative care.

Conditions

Aortic Diseases

Study ID

NCT04180553

Start date

Jan 15, 2020

Status verified date

Feb, 2021

Completion date

Dec 30, 2021

Anticipated

Primary completion date

Oct 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must be 18 years of age or older.

o There is no upper age limit for eligibility in this study.
  • Elective surgical procedures
  • Patients who are enrolled must be receiving open abdominal surgery for either occlusive disease (aortobifemoral bypass, transaortic endarterectomy) or aneurysmal disease (infrarenal, juxtarenal abdominal aortic aneurysms).
  • Patients must be deemed suitable operative candidates for open abdominal aortic surgery as decided upon by the surgical and perioperative medicine assessments.

Exclusion Criteria:

  • Thoracoabdominal aneurysms (Type IV or larger extent)
  • Hybrid procedures (Requiring both endovascular and open surgical reconstruction)
  • Pediatric vascular cases (Patients less than 18 years of age)
  • Emergency cases
  • American Society of Anesthesia (ASA) class 5 identified
  • Chronic renal failure requiring dialysis
  • Inability of patient to consent to study

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Point-Of-Care Ultrasound Guided Resuscitation

Intervention in this trial is randomization to POCUS management for goal-directed post-operative resuscitation for the first 48 hours of admission.Patients randomized to the use of POCUS will have a focused cardiac, thoracic, and IVC study performed post-operatively in PACU, as well as regular (BID) assessments on the inpatient ward for post-operative day one and two. Based on ultrasound findings, their fluid resuscitation will be guided to a fluid liberal or fluid restrictive strategy at the time of each assessment.

active comparator: Usual Care

The comparator arm in this trial is randomization to usual care. Participants randomized to control group for usual care will undergo resuscitation guided by modalities used currently, which can include both static and dynamic measures. These will include review of vital signs, biochemistry, and urine output as well as bedside physical exam. In this arm, patients will not undergo POCUS during their admission. IV fluid infusion rates as well as targets for IV boluses will be left to the discretion of the attending physician and can include hypotension, hypovolemia, as well as oliguria

Interventions

Point of Care Ultrasound (POCUS)

The intervention group will receive a 4-view transthoracic echocardiogram including Parasternal long axis, parasternal short axis, apical 4-chamber, and supplemental subcostal short-axis/4-chamber views as needed. A standard 4-view thoracic lung ultrasound study will assess the left and right anterior chest wall, anterior axillary regions, as well as the costophrenic angle and posterolateral regions. At 5 discrete time intervals post-operatively, POCUS assessments will be used to adjust fluid resuscitation to fluid liberal (2cc/kg/hr) or fluid restrictive (0.8cc/kg/hr). Routine vital signs, biochemistry, and urine output as well as bedside physical exam will be assessed as usual. IV boluses of crystalloid will be permitted to treat hypotension with SBP <90mmHg with clinical signs of hypovolemia, but oliguria will not be used as a marker to titrate fluid infusion rates. Blood transfusion may be used for post-operative bleeding or anemia as clinically indicated.

Usual Care

The control group for "usual care" will undergo resuscitation guided by modalities used currently, which can include both static and dynamic measures. These will include review of vital signs, biochemistry, and urine output as well as bedside physical exam. In this arm, patients will not undergo POCUS during their admission. IV fluid infusion rates as well as targets for IV boluses will be left to the discretion of the attending physician and can include hypotension, hypovolemia, as well as oliguria. Blood transfusion may be used for post-operative bleeding or anemia as clinically indicated.

Primary outcome measure

  • Feasibility - Recruitment [ Time Frame: 30 days ]
  • Feasibility - Successful Randomization [ Time Frame: 30 days ]
  • Feasibility - POCUS Study completion [ Time Frame: 30 days ]
  • Feasibility - Protocol Adherence [ Time Frame: 30 days ]
  • Feasibility - Successful Data Collection [ Time Frame: 30 days ]
  • Feasibility - Contamination rate [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Center - Victoria Hospital

Recruiting

London, Ontario, Canada, N6A5W9

Contacts

More Information

Sponsor

London Health Sciences Centre

Last update posted

Feb 24, 2021

Last verified

Feb, 2021

Keywords

  • Ultrasound
  • Goal-directed resuscitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre on 2021-02-24.