Recruiting

Q-NRG+ vs. V(Max)

Sponsor:

Boston Children's Hospital

Code:

NCT04482556

Conditions

Calorimetry, Indirect

Oxygen Consumption

Metabolism

Mechanical Ventilation

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Q-NRG+ Indirect Calorimetry Device

V(max) Encore Indirect Calorimetry Device

Study Details

Brief summary:

The overarching aim of this proposal is to examine the feasibility of the Q-NRG+ indirect calorimetry device and its agreement with (Vmax) Encore indirect calorimetry device in mechanically ventilated children. The overall hypothesis of this study is that the Q-NRG+ will provide minute-to-minute oxygen consumption (VO2) and carbon dioxide production (CO2) measurements that are in agreement with those obtained by the standard indirect calorimetry device currently used at our institution (Vmax Encore).

Conditions

Calorimetry, Indirect

Oxygen Consumption

Metabolism

Mechanical Ventilation

Study ID

NCT04482556

Start date

Jan 1, 2020

Status verified date

Dec, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children mechanically ventilated with endotracheal tube of tracheostomy in standard ventilatory modes such as SIMV-PC, SIMV-VC or PRVC
  • Age > 10 years AND weight > 10kg
  • FIO2 < 60%
  • PEEP < 8
  • ETT leak < 10%
  • The attending physician of record plans to order indirect calorimetry and considers research activity safe

Exclusion Criteria:

  • Hemodynamic instability (hypotension according to PALS/ACLS formula or requiring 2 or greater vasoactive infusions)
  • Presence of chest tubes with ongoing air leak
  • Patients requiring ECMO support
  • Patients undergoing end-of-life care
  • Primary provider declines enrollment.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Q-NRG+ Indirect Calorimetry Device

Q-NRG+ device will be compared to current V(max) device in each enrolled patient in subsequent, alternating fashion.

other: V(max) Encore Indirect Calorimetry Device

V(max) Encore device, currently institution's standard device, will be compared to Q-NRG+ device in each enrolled patient in subsequent, alternating fashion.

Interventions

Q-NRG+ Indirect Calorimetry Device

The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.

V(max) Encore Indirect Calorimetry Device

The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.

Primary outcome measure

  • Mean bias and limits of agreement between measured oxygen consumption (VO2) and carbon dioxide elimination (VCO2) in mechanically ventilated children assessed using the Q-NRG+ indirect calorimetry device and the V(max) Encore indirect calorimetry device. [ Time Frame: 1 hour/participant ]
  • Calculated total testing time, including calibration, required to complete a steady state indirect calorimetry measurement using the Q-NRG+ device and the V(max) Encore. [ Time Frame: 1 hour/participant ]

Central Contacts and Locations

Central contacts

Ben D Albert, MD

617-355-7327ben.albert@childrens.harvard.edu

Nilesh M Mehta, MD

617-355-7327Nilesh.Mehta@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ben Albert, MD

617-355-7327

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jan 3, 2024

Last verified

Dec, 2023

Keywords

  • Pediatrics
  • Indirect Calorimetry
  • Enteral Nutrition
  • Metabolism
  • Critical Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2024-01-03.