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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431064
• Other study ID #: IRB-P00025702
• Status: Recruiting
• Start date: June 21, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Boston Children's Hospital
• Contact: Viviane Nasr, MD
• Phone: 617-355-6225
• Email: viviane.nasr[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Blood Pressure
• Intravenous Fluid

Intervention

Other:
• Lung Recruitment Maneuver
Lung Recruitment Maneuver by Anesthesiologist
• Fluid Administration
Administration of IV Fluid by Anesthesiologist

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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