Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; Anesthesia; Intravenous Fluid
• Intervention / Treatment: Other: Lung Recruitment Maneuver; Other: Fluid Administration

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.

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Viviane Nasr, MD; Phone Number: 617-355-6225; Email: viviane.nasr@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Viviane Nasr, MD; Phone Number: 617-355-6225; Email: viviane.nasr@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical patients less than 18 years old; Patients less than 18 years old having surgery with general anesthesia at Boston Children's Hospital	Other: Lung Recruitment Maneuver; Lung Recruitment Maneuver by Anesthesiologist; Other: Fluid Administration; Administration of IV Fluid by Anesthesiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stroke volume	Evaluate Lung Recruitment Maneuver as a means to predict fluid responsiveness in mechanically ventilated pediatric patients in the operating room.	immediately before and after each intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in arterial compliance effect on Systolic Pressure Variation (mmHg)	Evaluate the effect of arterial stiffness on Systolic Pressure Variation (mmHg) in mechanically ventilated pediatric patients in the operating room.	immediately before and after each intervention
Change in arterial compliance effect on Pulse Pressure Variation (%)	Evaluate the effect of arterial stiffness on Pulse Pressure Variation (%) in mechanically ventilated pediatric patients in the operating room.	immediately before and after each intervention
Change in arterial compliance effect on Plethysmographic Variability Index (%)	Evaluate the effect of arterial stiffness on Plethysmographic Variability Index (%) in mechanically ventilated pediatric patients in the operating room.	immediately before and after each intervention

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Masimo Corporation
• Investigators: Principal Investigator: Viviane Nasr, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Estimated): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Infusions, Parenteral; Infusions, Subcutaneous; Fluid Therapy; Hypodermoclysis
• Other Study ID Numbers: IRB-P00025702

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No