RecruitingNot Applicable

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

United States48 participantsStarted 2018-06-21

Plain-language 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.

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in stroke volume

Timeframe: immediately before and after each intervention

Trial details

NCT IDNCT03431064

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Viviane Nasr, MD

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

View on ClinicalTrials.gov More Anesthesia trials