Clinical trial NCT03431064: Lung Recruitment Maneuver As a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
Official title: Lung Recruitment Maneuver As a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Intravenous Fluid
Blood Pressure
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2018-02-13
Enrollment: 48
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients less than 18 years old who are scheduled to undergo surgery with general anesthesia at Boston Children's Hospital

Brief summary: In this research study we want to learn more about using non-invasive tools as a way to predict whether or not a child under general anesthesia will require and respond to fluid administration.

It is important for an anesthesiologist to know if a child would respond to fluid administration so that they can provide the optimal intervention for low blood pressure and avoid unnecessary treatment.

Detailed description: In this research study we want to learn more about using non-invasive tools as a way to predict whether or not a child under general anesthesia will require and respond to fluid administration.

It is important for an anesthesiologist to know if a child would respond to fluid administration so that they can provide the optimal intervention for low blood pressure and avoid unnecessary treatment.

Eligibility criteria: Inclusion Criteria:

* 0 to \< 18 years old
* Undergoing surgery at Boston Children's Hospital under general anesthesia
* mechanically ventilated with an endotracheal tube
* Monitored with an indwelling radial arterial catheter as part of the anesthetic plan for the scheduled surgical procedure

Exclusion Criteria:

* Prematurity
* Low birth weight
* Congenital heart disease
* Left or right ventricular dysfunction
* Cardiac arrhythmia
* Pulmonary hypertension
* Preoperative parenchymal or interstitial lung disease
* Intracranial hypertension
* Poor transthoracic acoustic window
* Obesity
* Allergy to ultrasound transmission gel
* Need for single lung ventilation
* Systemic hypertension on antihypertensive medications

Primary outcomes:
measure: Change in stroke volume
timeFrame: immediately before and after each intervention
Secondary outcomes:
measure: Change in arterial compliance effect on Systolic Pressure Variation (mmHg)
timeFrame: immediately before and after each intervention
measure: Change in arterial compliance effect on Pulse Pressure Variation (%)
timeFrame: immediately before and after each intervention
measure: Change in arterial compliance effect on Plethysmographic Variability Index (%)
timeFrame: immediately before and after each intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Viviane Nasr, MD
role: PRINCIPAL_INVESTIGATOR
References: