UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051665 |
|---|---|
| Receipt number | R000058960 |
| Scientific Title | Investigation of the usefulness of pulmonary oxygen consumption determined from indirect calorimetry and hemodynamic parameters in the evaluation of severe respiratory disease |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/09/12 11:57:37 |
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Basic information
Public title
Investigation of the usefulness of pulmonary oxygen consumption determined from indirect calorimetry and hemodynamic parameters in the evaluation of severe respiratory disease
Acronym
Investigation of the usefulness of pulmonary oxygen consumption determined from indirect calorimetry and hemodynamic parameters in the evaluation of severe respiratory disease
Scientific Title
Investigation of the usefulness of pulmonary oxygen consumption determined from indirect calorimetry and hemodynamic parameters in the evaluation of severe respiratory disease
Scientific Title:Acronym
Investigation of the usefulness of pulmonary oxygen consumption determined from indirect calorimetry and hemodynamic parameters in the evaluation of severe respiratory disease
Region
| Japan |
Condition
Condition
Patients undergoing mechanical ventilation with tracheal intubation in the ICU due to severe respiratory disease
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the usefulness of delta VO2, which reflects the oxygen consumption of the lung itself, as an indicator of severity assessment, therapeutic response, and prognosis in severe respiratory disease.
* delta VO2 is defined as the difference between whole-body oxygen consumption (VO2 resp) obtained from an indirect calorimeter and oxygen consumption (VO2 fick) calculated from hemodynamic parameters using the reversed Fick equation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, we mainly examine three items:
1) the relationship between mortality and delta VO2,
2) the relationship between delta VO2 and the P/F ratio
3) the relationship between changes in delta VO2 (delta-delta VO2) and changes in the P/F ratio (delta P/F).
Key secondary outcomes
# Relationship between delta VO2, ScvO2, and O2 extraction rate (O2ER)
# Relationship between delta VO2 and CRP
# Relationship between delta VO2 and days of mechanical ventilation, length of stay in ICU, reintubation rate, SBT success/failure rate, and RSBI
(SBT: Spontaneous breathing trial, RSRI: Rapid Shallow Breathing Index)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Forty-three adult patients who were intubated and mechanically ventilated in the ICU of our hospital for severe respiratory disease and who met all of the following criteria:
1) An arterial catheter is inserted
2) Oximetry CV catheter is inserted
Key exclusion criteria
Exclude patients and timings with any of the following:
1) Timing of using extracorporeal circulation
2) Patients with an arteriovenous shunt
3) Timing within 10 minutes after changing ventilator settings
4) Cardiogenic pulmonary edema is determined to be the main cause of worsening respiratory status, or patients undergoing blood gas analysis from a CV catheter to evaluate respiratory status.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
0245471342
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
0245471342
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Fukushima
Tel
0245471041
fmurec@fmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data are collected at the timing of clinical arterial blood gas analysis. Since it is expected that about 1 to 10 sets of data can be collected per patient, we expect to collect about 200 sets of data in total. We collect the following items:
# Patient information: age, sex, height, weight, body surface area, disease name, underlying physical conditions, SOFA score
# Ventilator settings: mode, FiO2, tidal volume, PEEP, maximum airway pressure
# Results of arterial blood gas analysis: pH, PaCO2, PaO2, SaO2, Lactate, Hb
# Vital signs, ScvO2 measured by Oximetry centarl venous catheter (Edwards Lifesciences, USA), CO measured by FloTrac (Edwards Lifesciences, USA) , VO2fick during arterial blood gas analysis
# VO2resp and delta VO2 obtained from indirect calorimeter (Q-NRG+, Nihon Kohden, Tokyo, Japan)
# If ventilator PB840 or PB980 is used, work of breathing
# If using an esophageal pressure balloon, transpulmonary pressure
Ventilation management follows the usual management policy: 1) FiO2 to avoid excessive hyperoxia and hypoxemia, 2) moderate PEEP (at least 5 cmH2O, referring to the PEEP table), 3) Tidal volume is set about 6-8 ml per kg of ideal body weight.
In addition, in this study, 1.58 is used as the coefficient for the amount of oxygen [mL] that binds to 1 g of hemoglobin used when calculating VO2 fick. Although 1.34 or 1.39 have been used so far, these are calculated values under standard conditions (0 degree Celsius, 1 atmospheric pressure) and may cause errors in actual living organisms. A factor of 1.58 (JA Clin Rep 2020;6:62) at 37 degrees Celsius is used in this study.
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058960
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