UMIN-CTR Clinical Trial

Basic information
Public title	Effect of heat and moisture exchanger filter on end-tidal carbon dioxide measurement with mainstream capnography in critically ill patients: A single-center prospective observational study
Acronym	Effect of heat and moisture exchanger filter on end-tidal carbon dioxide measurement with mainstream capnography in critically ill patients: A single-center prospective observational study
Scientific Title	Effect of heat and moisture exchanger filter on end-tidal carbon dioxide measurement with mainstream capnography in critically ill patients: A single-center prospective observational study
Scientific Title:Acronym	Effect of heat and moisture exchanger filter on end-tidal carbon dioxide measurement with mainstream capnography in critically ill patients: A single-center prospective observational study
Region	Japan

Condition
Condition	Adult critically ill patients receiving mechanical ventilation
Classification by specialty	Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether end-tidal carbon dioxide (EtCO2) measurement on the ventilator side of the heat and moisture exchanger filter (HME) is non-inferior to EtCO2 measurement on the patient side of the HME in adult critically ill patients receiving mechanical ventilation.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Absolute differences between arterial partial pressure of carbon dioxide (PaCO2) and EtCO2. Delta EtCO2 of ventilator side= absolute differences between PaCO2 and EtCO2 measured on the ventilator side of the HME filter. Delta EtCO2 of patient side= absolute differences between PaCO2 and EtCO2 measured on the patient side of the HME filter.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Adult patients (20 years or older) admitted to the intensive care unit and received mechanical ventilation through orotracheal or tracheostomy tube. 2. The respiratory circuit was humidified with heat and moisture exchanger filter. 3. Patients with arterial line.
Key exclusion criteria	1.Pregnancy 2.Patients previously enrolled in this study 3.Refusal of study participation 4.Patients do not meet the safety criteria. If patients have any of the following physiological signs, the patients are judged not meeting the safety criteria. Ventilator settings -PEEP 10 cmH2O or more -Fraction of inspired oxygen 0.6 or more Heart rate -below 40 bpm, 130 bpm or more Mean arterial pressure -below 60 mm Hg, 110 mm Hg or more Oxygen saturation -below 90% Respiratory rate -40 breaths per minute or more Body temperature -below 36 degrees Celsius, 38.5 degrees Celsius or more 5. Treating physicians judged that study participation of the patient is inappropriate.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Tamashiro
Organization	Okinawa Chubu Hospital
Division name	Department of Clinical engineering
Zip code	904-2293
Address	281 Miyazato, Uruma, Okinawa 904-2293, Japan
TEL	098-973-4111
Email	tamashiro_satoshi@hosp.pref.okinawa.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Tamashiro
Organization	Okinawa Chubu Hospital
Division name	Department of Clinical engineering
Zip code	904-2293
Address	281 Miyazato, Uruma, Okinawa 904-2293, Japan
TEL	098-973-4111
Homepage URL
Email	tamashiro_satoshi@hosp.pref.okinawa.jp

Sponsor
Institute	Okinawa Chubu Hospital, Department of Clinical engineering
Institute
Department

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	Okinawa Chubu Hospital Research ethics committees
Address	281 Miyazato, Uruma, Okinawa, Japan
Tel	098-973-4111
Email	tamashiro_satoshi@hosp.pref.okinawa.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	沖縄県立中部病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s10877-022-00901-6
Number of participants that the trial has enrolled	37
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	Completed
Date of protocol fixation	2019 Year 06 Month 19 Day
Date of IRB	2019 Year 06 Month 19 Day
Anticipated trial start date	2019 Year 07 Month 16 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 12 Month 25 Day
Date analysis concluded	2022 Year 04 Month 01 Day

Other

Other related information

Sample size calculation: The calculated sample size is 35 patients based on a non-inferiority margin of +1mm Hg for a difference in delta EtCO2 of ventilator side minus delta EtCO2 of patient side, with a 1-sided alpha of 5%, and 90% power, assuming standard deviation of the difference as 1.5 mmHg. A non-inferiority margin of +1mm Hg was set based on minimum clinically meaningful difference. The standard deviation of 1.5 mm Hg was set based on the results of pilot sampling. Statistical analysis: We will declare non-inferiority if the upper limit of the 1-sided 95% interval of the difference in delta EtCO2 of ventilator side minus delta EtCO2 of patient side is less than the non-inferiority margin of + 1mm Hg.

Management information
Registered date	2019 Year 07 Month 09 Day
Last modified on	2022 Year 08 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042306