UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Therapeutic evaluation of Computed Tomography findings for efficacy of prone ventilation in Acute Respiratory Distress Syndrome patients with abdominal surgery
Title of the study (Brief title)	Therapeutic evaluation of Computed Tomography findings for efficacy of prone ventilation in Acute Respiratory Distress Syndrome patients with abdominal surgery
Region	Japan

Condition
Condition	ARDS
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the association between computed tomography findings and the efficacy of prone ventilation for patients with ARDS after abdominal surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	weaning from mechanical ventilation
Key secondary outcomes	patient characteristics, duration of ICU stay, outcome(28days, 90 days), P/F ratio

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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Participants were patients admitted to the intensive care unit (ICU) in our hospital between 2004 and 2018 who had developed ARDS following surgery for intra-abdominal infection and who had undergone lung CT on admission to the ICU.
Key exclusion criteria	1) Patients with mechanical ventilation management less than 72 hours 2) Pediatric patients under 15 years of age
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroomi Tatsumi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South1 West15, Chuo-ku, Sapporo
TEL	011-611-2111
Email	tatsumi@qc4.so-net.ne.jp

Public contact
Name of contact person	MAsayuki Akatsuka
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South1 West15, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	m_a_let_go@yahoo.co.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Weaning from mechanical ventilation was significantly earlier in the prone group with DLA than in the supine group with DLA. The mortality rate after 28 days and 90 days was significantly lower for the prone group with DLA than for the supine group with DLA.

Management information
Registered date	2018 Year 11 Month 10 Day
Last modified on	2018 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039738