AnesthesiaNCT03431064
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
An observational study of Anesthesia and Intravenous Fluid, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Anesthesia, Intravenous Fluid, Blood Pressure
- What is being tested?
- Lung Recruitment Maneuver and Fluid Administration
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Child
Study population: Patients less than 18 years old who are scheduled to undergo surgery with general anesthesia at Boston Children's Hospital
Who may be able to join
- 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
Who cannot join
- Prematurity
- Low birth weight
- Congenital heart disease
- Left or right ventricular dysfunction
- Cardiac arrhythmia
- Pulmonary hypertension
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Viviane Nasr, MD, 617-355-6225, viviane.nasr@childrens.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Anesthesia, Intravenous Fluid, Blood Pressure
- Being tested
- Lung Recruitment Maneuver, Fluid Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Recruitment ManeuverOther
Lung Recruitment Maneuver by Anesthesiologist
Fluid AdministrationOther
Administration of IV Fluid by Anesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients less than 18 years old | Patients less than 18 years old having surgery with general anesthesia at Boston Children's Hospital Receives: Other: Lung Recruitment Maneuver; Other: Fluid Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stroke volume
Evaluate Lung Recruitment Maneuver as a means to predict fluid responsiveness in mechanically ventilated pediatric patients in the operating room.
Measured: immediately before and after each intervention
Secondary outcomes (3)
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.
Measured: immediately before and after each intervention
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.
Measured: immediately before and after each intervention
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.
Measured: immediately before and after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start21 Jun 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Principal investigator, Viviane Nasr, Boston Children's Hospital
- Investigators
- Viviane Nasr, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431064
- Sponsor's protocol ID
- IRB-P00025702
- Status last verified
- Nov 2025
- First submitted
- 2 Feb 2018
- Last updated
- 12 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- ClinicalTrials.gov ID
- NCT03431064
- Acronym / sponsor ID
- IRB-P00025702
- Conditions
- Anesthesia, Intravenous Fluid, Blood Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients less than 18 years old | – | Other: Lung Recruitment Maneuver, Other: Fluid AdministrationPatients less than 18 years old having surgery with general anesthesia at Boston Children's Hospital |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients less than 18 years old who are scheduled to undergo surgery with general anesthesia at Boston Children's Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Prematurity
- Low birth weight
- Congenital heart disease
- Left or right ventricular dysfunction
- Cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Recruitment ManeuverLung Recruitment Maneuver by Anesthesiologist | Other | Surgical patients less than 18 years old |
| Fluid AdministrationAdministration of IV Fluid by Anesthesiologist | Other | Surgical patients less than 18 years old |
Primary outcome
Change in stroke volume
Time frame: 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.
3 secondary outcomes
Change in arterial compliance effect on Systolic Pressure Variation (mmHg)
Time frame: immediately before and after each intervention
Change in arterial compliance effect on Pulse Pressure Variation (%)
Time frame: immediately before and after each intervention
Change in arterial compliance effect on Plethysmographic Variability Index (%)
Time frame: immediately before and after each intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viviane Nasr, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Intravenous Fluid, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane Nasr, MD (617-355-6225, viviane.nasr@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stroke volume (time frame: immediately before and after each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.