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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031410
Receipt No. R000035867
Scientific Title Relationship between Mallampati classification and frequency of respiratory depression after caesarian section with Single Shot Spinal Anesthesia
Date of disclosure of the study information 2018/02/22
Last modified on 2019/08/30

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Basic information
Public title Relationship between Mallampati classification and frequency of respiratory depression after caesarian section with Single Shot Spinal Anesthesia
Acronym Relationship between Mallampati classification and respiratory depression after cesarean section
Scientific Title Relationship between Mallampati classification and frequency of respiratory depression after caesarian section with Single Shot Spinal Anesthesia
Scientific Title:Acronym Relationship between Mallampati classification and respiratory depression after cesarean section
Region
Japan

Condition
Condition Post caesarian section
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the frequency of respiratory depression (bradypnea, apnea, temporary hypopnea, sustained hypopnea) in women undergoing elective caesarian section receiving Single Shot Spinal Anesthesia, having either Mallampati classification 1-2 or 3-4. Respiratory depression will be assessed using a capnometer (capnometer;OLG-3800. device; cap-ONE YG-122T, Nihon Koden, Japan). In addition, we will investigate whether the non-invasive Early Sense monitor can detect respiratory depression.
Respiratory depression is defined as:
1.Bradypnea (Early Sense & capnometer)
RR9bpm or less(capnometer), or 6-9bpm(Early Sense) for 120seconds or more.
2.Apnea (capnometer only)
Maximal PETCO2 less than 5mmHg for 15 seconds or more up to 120 seconds.
3.Temporary hypopnea:indicating decrease of tidal volume(Early Sense and/or capnometer)
PETCO2 5mmHg or more to less than 15mmHg for 15 seconds or more up to 120 seconds.
4.Sustained hypopnea (capnometer and/or Early Sense)
PETCO2 more than 45mmHg for more than 120 seconds.
Basic objectives2 Others
Basic objectives -Others We will compare respiratory depression in women who underwent caesarian section by spinal anesthesia with neuraxial morphine. We will compare frequency of respiratory depression events in two subgroups (Mallampati classification 1-2 or 3-4).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will compare respiratory depression in women who underwent caesarian section by spinal anesthesia with neuraxial morphine. We will compare frequency of respiratory depression events in two subgroups (Mallampati classification 1-2 or 3-4).
Key secondary outcomes Association with respiratory depression of the following: Oxygen saturation, BMI, Questionnaire (STOP) to predict risk of airway obstruction (S:having snoring or not,T:tiredness,daytime somnolence,O:observating apnea, P:presence of high blood pressure), body movement.
In addition, we will compare respiratory rate measured by capnometry with respiratory rate measured noninvasively by Early Sense.

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 Female
Key inclusion criteria Parturients undergoing elective caesarian delivery

Patient who are available to provide written consent prior to surgery

Use of neuraxial anesthesia
Key exclusion criteria Emergent cases
Need for mechanical ventilation postoperatively
Conversion to general anesthesia
Transfer to ICU
Newborn complications
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yasuko
Middle name
Last name Nagasaka
Organization St. Lukes International Hospital
Division name Department of Anesthesiology
Zip code 104-8560
Address 9-1 Akashi-cho, Chuo-ku, Tokyo
TEL 03(3541)5151
Email nagasaka@luke.ac.jp

Public contact
Name of contact person
1st name Susumu
Middle name
Last name Yoshida
Organization St. Lukes International Hospital
Division name Department of Anesthesiology
Zip code 104-8560
Address 9-1 Akashi-cho, Chuo-ku, Tokyo
TEL 03(3541)5151
Homepage URL
Email susuyo@luke.ac.jp

Sponsor
Institute St. Lukes International University
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 St. Lukes International Hospital IRB
Address 9-1 Akashi-cho, Chuo-ku, Tokyo
Tel 03(5550)2423
Email kenkyukikaku@luke.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
2018 Year 02 Month 22 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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 12 Day
Date of IRB
2018 Year 01 Month 12 Day
Anticipated trial start date
2018 Year 03 Month 27 Day
Last follow-up date
2019 Year 06 Month 07 Day
Date of closure to data entry
2022 Year 01 Month 31 Day
Date trial data considered complete
2022 Year 01 Month 31 Day
Date analysis concluded
2022 Year 01 Month 31 Day

Other
Other related information Study design:
Prospective observational study

Monitoring:
Adding to routine intermittently vital signs measurement (SpO2, NIBP, PR, RR, Temp, Pain), end-tidal carbon dioxide partial pressure, exhaled carbon dioxide waveform and respiratory rate will be continuously monitored using capnometer (capnometer; OLG-3800. device; cap-ONE, Nihon Koden, Japan )by the ward nurses for 24 hours postoperatively. If patient temporarily wear off the capnometer for eating or walking during study time, put their behavior in the behavior record simply by themselves.
Also, RR will be monitored using the Early Sense system.
Data collection stop 24 hours after surgery or sooner per patient request.

Management information
Registered date
2018 Year 02 Month 21 Day
Last modified on
2019 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035867

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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