UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055489 |
|---|---|
| Receipt number | R000057392 |
| Scientific Title | Investigation of the effect of positive pressure ventilation before extubation using Electrical impedance tomography |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2024/09/11 17:45:01 |
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Basic information
Public title
Investigation of the effect of positive pressure ventilation before extubation using Electrical impedance tomography
Acronym
Investigation of the effect of positive pressure ventilation before extubation using Electrical impedance tomography
Scientific Title
Investigation of the effect of positive pressure ventilation before extubation using Electrical impedance tomography
Scientific Title:Acronym
Investigation of the effect of positive pressure ventilation before extubation using Electrical impedance tomography
Region
| Japan |
Condition
Condition
Intubated patient
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effect of positive pressure ventilation before extubation on respiratory physiology after extubation using intraesophageal pressure and electrical impedance tomography: EIT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
work of breathing (pressure time product with esophageal pressure), transpulmonary pressure (inspiratory transpulmonary pressure, delta transpulmonary pressure), oxygenation after extubation, end-expiratory lung volume (end-expiratory impedance), ventilation distribution (tidal impedance variation), and pendelluft phenomenon.
Key secondary outcomes
Successful weaning from ventilator
Respiratory failure and reintubation rate at 72 hours after extubation
Respiratory complications (pneumonia, hypoxemia, upper airway obstruction, bronchospasm, etc.) for 5 days after extubation or until ICU discharge
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1) Considering weaning from the ventilator, patients scheduled to undergo SBT will be fitted with intraesophageal pressure monitor and EIT for monitoring prior to SBT (Monitoring 1).
2) Patients in both groups will undergo SBT (CPAP+PS mode, PSV 5 cmH2O, PEEP 5 cmH2O) for 30 minutes and undergo intraesophageal pressure + EIT monitoring. (Monitoring 2)
3) In Group A, positive pressure ventilation (CPAP+PS mode, PSV 15 cmH2O, PEEP 10 cmH2O) is performed for 30 minutes, followed by 30 minutes of management in ATC mode. In both cases, intraesophageal pressure + EIT monitoring will be performed. (Monitoring 3)
4) The SBT setting is returned again and continued for 30 minutes, and intraesophageal pressure + EIT monitoring is performed. (Monitoring 4)
5) In Group A, ATC mode is performed for 30 minutes, and intraesophageal pressure + EIT monitoring is performed. (Monitoring 5).
Interventions/Control_2
1) Considering weaning from the ventilator, patients scheduled to undergo SBT will be fitted with an intraesophageal pressure monitor and EIT and monitored before SBT is performed (Monitoring 1).
2) Perform SBT (CPAP+PS mode, PSV 5 cmH2O, PEEP 5 cmH2O) on the patient for 30 minutes and perform intraesophageal pressure + EIT monitoring. (Monitoring 2)
3) Group B will perform ATC mode for 30 minutes. Intraesophageal pressure + EIT monitoring will be performed. (Monitoring 3)
4) The SBT setting is returned again and continued for 30 minutes, and intraesophageal pressure + EIT monitoring is performed. (Monitoring 4)
5) In Group B, positive pressure ventilation (CPAP + PS mode, PSV 15 cmH2O, PEEP 10 cmH2O) is performed for 30 minutes, followed by 30 minutes of management in ATC mode. In both cases, intraesophageal pressure + EIT monitoring will be performed. (Monitoring 5).
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients 18 years of age or older who have been on ventilatory management in the ICU for at least 48 hours and are considered for weaning from the ventilator (SBT can be cleared).
Key exclusion criteria
Patients who cannot maintain airway patency (impaired consciousness, weak cough reflex, high airway secretions, positive cufflink test, etc.), severely obese (BMI>35 kg/m2), patients with chest trauma or other difficulties in EIT monitoring, post esophageal surgery, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | jun |
| Middle name | |
| Last name | oto |
Organization
The University of Tokushima Hospital
Division name
Department of Emergency and Intensive Care Medicine
Zip code
770-8503
Address
Tokushima city, Kuramoto town, 2-50-1
TEL
088-633-9347
takuya.takashima.2@tokushima-u-ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Takashima |
Organization
The University of Tokushima Hospital
Division name
Department of Emergency and Intensive Care Medicine
Zip code
770-8503
Address
Tokushima city, Kuramoto town, 2-50-1
TEL
088-633-9347
Homepage URL
takuya.takashima.2@tokushima-u-ac.jp
Sponsor or person
Institute
The University of Tokushima Hospital
Department of Emergency and Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokushima Hospital
Address
Tokushima city, Kuramoto town, 2-50-1
Tel
088-633-9347
first-ec@tokushima-u.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
| 2024 | Year | 09 | Month | 11 | 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 | 05 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2024 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057392
