UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037317 |
|---|---|
| Receipt number | R000042306 |
| 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 |
| Date of disclosure of the study information | 2019/07/16 |
| Last modified on | 2022/08/08 11:47:02 |
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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
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
tamashiro_satoshi@hosp.pref.okinawa.jp
Sponsor or person
Institute
Okinawa Chubu Hospital, Department of Clinical engineering
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
Okinawa Chubu Hospital Research ethics committees
Address
281 Miyazato, Uruma, Okinawa, Japan
Tel
098-973-4111
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042306
