Pulse CONtour and BIoimpedance for Measurements of Stroke Volume During Changes in CARdiac Preload

NCT04231656 | Completed

• 2 other identifiers: 2019_462019-A02697-50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid therapy guided by stroke volume response to repeated fluid challenges is used for hemodynamic optimization during general anesthesia. Two types of devices that measure stroke volume non-invasively are primarily available for intermediate-risk surgery under general anesthesia. They are based on two different techniques, (1) pulse contour analysis, and (2) transthoracic bioimpedance. They have never been compared with each other. Therefore, it is not known (1) whether they are interchangeable for the measurement of stroke volume changes (usually assessed as the "concordance" of two techniques), and (2) whether one is better than the other. The aim is to study the concordance of these two non-invasive hemodynamic devices. it will use both of them in patients undergoing intermediate risk surgery. They will be tested during modifications of cardiac preload induced by Trendelenburg and anti-Trendelenburg positioning, as well as during intraoperative fluid challenges, vasopressor boluses and alveolar recruitment maneuvers.

Conditions

Hemodynamic, Monitoring; Anesthesia; Blood Pressure

Keywords

Non-invasive; Stroke volume; Cardiac preload; Interchangeability; Bioelectrical impedance; Pulse contour analysis

Outcome Measures

Primary Outcomes (1)

• concordance of stroke volume changes measured with each monitor during the standardized maneuvers of sequences A and B (total: 6 observations per individual).

  4-quadrant plot

  during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B

Secondary Outcomes (7)

• Fluid responsiveness defined by areas under the Receiver Operating Characteristic curve (sensitivity and specificity)

  during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B

• concordance of stroke volume changes measured with each monitor during the standardized maneuvers mimicking preload decrease.

  during each changes of positioning where cardiac preload is supposed to decrease (i.e., for 1-2 minutes in one out of two condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B

• concordance of stroke volume changes measured with each monitor during the standardized maneuver mimicking preload increase.

  during each changes of positioning where cardiac preload is supposed to increase (i.e., for 1-2 minutes in one out of two condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B

• concordance of stroke volume changes measured with each monitor during the surgical procedure (fluid challenges, vasopressor boluses, alveolar recruitment maneuver).

  throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 5-20 minutes that can occur several times during surgery

• interchangeability of stroke volume measurements with each monitor during sequences A and B

  before and after each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B

Study Arms (2)

Sequence A before sequence B

EXPERIMENTAL

Patients eligible for intermediate risk surgery requiring the placement of an invasive continuous blood pressure measurement device and stroke volume monitoring for fluid management. Sequence A of positioning (before the procedure), and sequence B after the procedure.

Device: CLEARSIGHT and NICCOMO measurements in sequence A; Device: CLEARSIGHT and NICCOMO measurements in sequence B

Sequence B before sequence A

EXPERIMENTAL

Patients eligible for intermediate risk surgery requiring the placement of an invasive continuous blood pressure measurement device and stroke volume monitoring for fluid management. Sequence B of positioning before the procedure, and sequence A after the procedure.

Device: CLEARSIGHT and NICCOMO measurements in sequence A; Device: CLEARSIGHT and NICCOMO measurements in sequence B

Interventions

CLEARSIGHT and NICCOMO measurements in sequence A DEVICE

Starting from 0° position, shift to position +20°, then tilt to -20°, and finally back to the 0° position.

Also known as: CLEARSIGHT and NICCOMO devices (both used during each sequence)

Sequence A before sequence B; Sequence B before sequence A

CLEARSIGHT and NICCOMO measurements in sequence B DEVICE

Starting from 0° position, shift to position -20°, then tilt to +20°, and finally back to the 0° position and collect the last group of figures.

Also known as: CLEARSIGHT and NICCOMO devices (both used during each sequence)

Sequence A before sequence B; Sequence B before sequence A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible and suitable for intermediate risk surgery, validated by anaesthesia consultation.
• There is no definitive definition of intermediate risk. By reference to the literature, surgeries longer than 2 hours (excluding "low risk") and less than 3% postoperative mortality (excluding high-risk surgery). It includes the majority of non-serious visceral (abdominal and gynecological) surgery, plastic or cervical-facial surgery for neoplastic removal or long-term reconstruction, or long-term spinal surgery or neurosurgery of the base of the skull.
• \- For which the anesthesiologist in charge has planned an invasive monitoring (radial catheter) of arterial blood pressure.

You may not qualify if:

• Urgent surgery
• Intracranial hypertension
• Orthostatic hypotension
• Extreme anthropometry: weight \>150 kg and 30 kg, size 120 cm and \>230 cm
• Related to NICCOMO monitoring:
• Rhythmic anomaly: Atrial fibrillation, tachycardia with heart rate \>200 beats per minute.
• Aortic disease: Severe sclerosis
• Valve dysfunction: severe aortic regurgitation,
• Patient with aortic prosthesis or pacemaker using impedance detection.
• Occurrence of tachycardia \> 200 bpm, occurrence of hypertension with mean arterial pressure \>130 mm Hg
• Simultaneous use of electrical cauterization systems during surgical procedures
• Septic shock
• Related to CLEARSIGHT monitoring
• Patient with prior distal perfusion disorders
• Lower extremity obliterans arteritis stage IV

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU Lille

Lille, 59037, France

Location

Study Officials

• Benoit Tavernier, MD,PhD

  University Hospital Lille, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The primary outcome will be based on measurements performed during a sequence of position changes. Sequence A will consist of starting from 0° position, shift to position +20°, then tilt to -20°, and finally back to the 0° position. Sequence B will consist of starting from 0° position, shift to position -20°, then tilt to +20°, and finally back to the 0° position. Patients will be randomized to take sequence A before the procedure, and then the sequence B at the end of the procedure, or vice-versa (sequence B before sequence A). The randomization is not intended to compare the two groups with each other, but only to compensate for a possible"order-effect" in the execution of the maneuvers.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: February 12, 2020
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)