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

NCT03431064 | Recruiting

• 1 other identifier: IRB-P00025702
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Intravenous Fluid; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in arterial compliance effect on Systolic Pressure Variation (mmHg)

  immediately before and after each intervention

• Change in arterial compliance effect on Pulse Pressure Variation (%)

  immediately before and after each intervention

• Change in arterial compliance effect on Plethysmographic Variability Index (%)

  immediately before and after each intervention

Study Arms (1)

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; Other: Fluid Administration

Interventions

Lung Recruitment Maneuver OTHER

Lung Recruitment Maneuver by Anesthesiologist

Surgical patients less than 18 years old

Fluid Administration OTHER

Administration of IV Fluid by Anesthesiologist

Surgical patients less than 18 years old

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Masimo Corporation: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Hypodermoclysis

Intervention Hierarchy (Ancestors)

Infusions, Subcutaneous; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics; Fluid Therapy

Study Officials

• Viviane Nasr, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviane Nasr, MD

CONTACT

617-355-6225; viviane.nasr@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 13, 2018
• Study Start: June 21, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)