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

Recruiting

• Conditions: Blood Pressure; Anesthesia; Intravenous Fluid
• Interventions: Other: Lung Recruitment Maneuver; Other: Fluid Administration

• Registration Number: NCT03431064
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-13
• Study Start: 2018-06-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical patients less than 18 years old	Lung Recruitment Maneuver	Patients less than 18 years old having surgery with general anesthesia at Boston Children's Hospital
Surgical patients less than 18 years old	Fluid Administration	Patients less than 18 years old having surgery with general anesthesia at Boston Children's Hospital

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States