NCT04205422

Brief Summary

Adequate supply of energy is an essential part of the overall treatment of critically ill patients and adjustment of energy requirements of patients is important clinical evolution .The adequate assessment of energy expenditure is the basis of effective nutri¬tional planning.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

December 18, 2019

Last Update Submit

December 18, 2019

Conditions

Mechanical Ventilation

Keywords

metabolic requirementsrespiratory mechanics

Outcome Measures

Primary Outcomes (1)

  • energy expenditure

    energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator

    48 hours after enrollment

Secondary Outcomes (3)

  • arterial oxygen tension

    48 hours after enrollment

  • arterial carbon dioxide tension

    48 hours after enrollment

  • arterial pH

    48 hours after enrollment

Study Arms (2)

BIPAP group

ACTIVE COMPARATOR

Biphasic Intermittent Positive Airway Pressure group

Procedure: BIPAP

APRV group

ACTIVE COMPARATOR

Airway Pressure Release Ventilation group:

Procedure: APRV

Interventions

BIPAPPROCEDURE

Biphasic Intermittent Positive Airway Pressure

BIPAP group
APRVPROCEDURE

Airway Pressure Release Ventilation

APRV group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Critically ill trauma patients need mechanical ventilation

You may not qualify if:

  • Pregnant patient.
  • Air leak from the chest tube.
  • Patient with body temperature \> 39 Celsius.
  • Acute hepatitis or severe liver disease (Child-Pugh class C).
  • Left ventricular ejection fraction less than 30%.
  • Heart rate less than 50 beats/min.
  • Second or third-degree heart block.
  • Systolic pressure \< 90 mmHg despite of infusion of 2 vasopressors.
  • Patients with known endocrine dysfunction.
  • Patient with hypothermia
  • Patient on Positive end expiratory pressure more than 14 cmH2o

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 19, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

June 1, 2022

Last Updated

December 20, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share