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

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03431064
• Collaborator: Masimo Corporation (Industry)
• Enrollment: 48
• Location: 1
• Anticipated Duration (Months): 54.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Intravenous Fluid; Blood Pressure	Other: Lung Recruitment Maneuver; Other: Fluid Administration

Study Design

• Study Type: Observational
• Anticipated Enrollment: 48 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
• Actual Study Start Date: Jun 21, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Boston Children's Hospital
• Masimo Corporation

Investigators

• Principal Investigator: Viviane Nasr, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Viviane Nasr, Cardiac Anesthesiologist, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT03431064
• Other Study ID Numbers: IRB-P00025702
• First Posted: Feb 13, 2018
• Last Update Posted: Oct 5, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 5, 2021