UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031410 |
|---|---|
| Receipt number | 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 | 2022/08/29 17:06:13 |
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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
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
susuyo@luke.ac.jp
Sponsor or person
Institute
St. Lukes International University
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
St. Lukes International Hospital IRB
Address
9-1 Akashi-cho, Chuo-ku, Tokyo
Tel
03(5550)2423
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
https://luke.bvits.com/rinri/Apply/show.aspx?TYPE=4&ID=7083
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/twmuj/advpub/0/advpub_2021017/_article
Number of participants that the trial has enrolled
272
Results
There were 100 patients with MMP 1-2, and 90 patients with MMP 3-4. Bradypnea was observed in 55 patients (MMP 1-2, 55%) vs 55 patients (MMP 3-4 61%), p=0.394. Apnea was observed in 77 patients (MMP 1-2, 77%) vs 75 patients (MMP 3-4. 83%), p=0.276. Temporary hypopnea was observed in 68 patients (MMP 1-2, 68%) vs 76 patients (MMP 3-4. 84%), p=0.008. No sustained hypopnea events were noted in any patients.Desaturation events were 40 patients vs 40patients(40% vs 44.4%, p=0.536).
Results date posted
| 2022 | Year | 02 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Consent was obtained from 272 patients. 72 patients were excluded from the study due to the nature of surgery (emergent CS, n=45), equipment availability (n=9), conversion to general anesthesia (n=7), no administration of morphine (n=4), surgery cancellation (n=5), withdrawal of consent (n=1), and fetal complications (n=1). Of the remaining 200 patients, 10 were excluded due to insufficient data, resulting in 190 patients for the final data analysis.
Adverse events
none
Outcome measures
Primary endpoint:
To find out prevalence of Respiratoy Depression(RD) events in patients receiving intrathecal morphine for CS. We defined RD as the presence of any of the following within the 24-hour post-cesarean monitoring period:
#1. Bradypnea: respiratory rate of less than 10 breaths/min for more than 2 minutes .
#2. Apnea: maximal PEnd-Tidal(ET)CO2 value less than 5 mmHg for more than 15 seconds, and less than 2 minutes.
#3. Temporary hypopnea (decrease in ventilation): maximum PETCO2 value between 5 mmHg and 15 mmHg for at least 15 seconds, lasting up to 2 minutes.
#4. Persistent hypopnea: PETCO2 greater than 45 mmHg for more than 2 minutes.
Secondary endpoints:
Our secondary endpoint is the presence of any of the four previously defined RD events with desaturation of SpO2<90% occurring within 1 minute before or after the RD event. Moreover, the following patient characteristics were noted for subsequent regression analysis as potential predictors of RD: Body mass index (BMI), thyromental distance (TMD), STOP questionnaire score (S: snoring, T: tiredness or day somnolence, O: observed sleep apnea, P: hypertension).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | 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
| 2022 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035867
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