UMIN-CTR Clinical Trial

Basic information
Public title	Diaphragmatic excursion and velocity during cough and extubation outcomes in patients who have passed a spontaneous breathing trial
Acronym	Diaphragmatic excursion and velocity during cough and extubation outcomes
Scientific Title	Diaphragmatic excursion and velocity during cough and extubation outcomes in patients who have passed a spontaneous breathing trial
Scientific Title:Acronym	Diaphragmatic excursion and velocity during cough and extubation outcomes
Region	Japan

Condition
Condition	All mechanically ventilated patients >18 years old who have been endotracheally intubated for respiratory failure and who have passed a SBT and follow commands will be considered for study inclusion. Successful completion of an SBT will be determined by the standard Tokyo Bay Urayasu Ichikawa Medical center Intensive Care Weaning Protocols (no evidence of severe anxiety, dyspnea, excessive accessory muscle use, RSBI>105 breaths/min/L, and adequate gas exchange on 50% FIO2 or less).
Classification by specialty	Medicine in general Surgery in general Vascular surgery Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine if diaphragmatic motion and the velocity (cm/sec) during cough measured by ultrasonography can be predictors for effective cough to clear secretions, therefore predictors for successful extubation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Re-intubation
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	All mechanically ventilated patients >18 years old who have been endotracheally intubated for respiratory failure and who have passed a SBT and follow commands
Key exclusion criteria	Patients with documented upper airway edema or known fixed airway obstruction will be excluded from the study
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Norisue
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Pulmonary and Critical Care Medicine
Zip code	2790001
Address	3-4-32 Todaijima, Urayasushi, Chiba, Japan
TEL	+8108058959696
Email	norisue.yasuhiro@gmail.com

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Norisue
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Pulmonary and Critical Care Medicine
Zip code	2790001
Address	3-4-32 Todaijima, Urayasushi, Chiba, Japan
TEL	+8108058959696
Homepage URL
Email	norisue.yasuhiro@gmail.com

Sponsor
Institute	Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

Funding Source
Organization	NA
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	Tokyo Bay Urayasu Ichikawa Medical Center
Address	3-4-32 Todaijima,
Tel	047-351-3101
Email	norisue.yasuhiro@gmail.com

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	2017 Year 04 Month 16 Day

Related information
URL releasing protocol	unpublished
Publication of results	Unpublished

Result
URL related to results and publications	unpublished
Number of participants that the trial has enrolled	252
Results	Both PCED and diaphragm peak velocity during cough showed significant association with CPF, while only PCED predicted extubation failure with area under the curve of 0.791 (95% Cl 0.668-0.914).
Results date posted	2020 Year 04 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Two hundred fifty-two (252) mechanically ventilated patients with a successful SBT were enrolled in a prospective cohort study.
Participant flow	Two hundred fifty-two (252) mechanically ventilated patients with a successful SBT were enrolled in a prospective cohort study.
Adverse events	None
Outcome measures	Extubation failure
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 16 Day
Date of IRB	2017 Year 04 Month 11 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NA

Management information
Registered date	2017 Year 04 Month 16 Day
Last modified on	2021 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030968