UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049292 |
|---|---|
| Receipt number | R000056139 |
| Scientific Title | Comparative study of C-E and V-E techniques of mask ventilation in obese patients undergoing general anaesthesia |
| Date of disclosure of the study information | 2022/10/23 |
| Last modified on | 2022/10/23 01:32:06 |
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Basic information
Public title
Comparative study of C-E and V-E techniques
of mask ventilation in obese patients undergoing general anaesthesia
Acronym
CE vs VE in MV in obese in GA
Scientific Title
Comparative study of C-E and V-E techniques
of mask ventilation in obese patients undergoing general anaesthesia
Scientific Title:Acronym
CE vs VE in MV in obese in GA
Region
| Asia(except Japan) |
Condition
Condition
Completed clinical trial
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare CE and VE techniques of mask ventilation, expired tidal volumes and peak airway pressures in Obese patient undergoing general Anaesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Expired tidal volumes measured during mask ventilation in obese patients undergoing general anaesthesia
Key secondary outcomes
1) Peak airway pressures
2) Heart rate
3) Non invasive blood pressures
4) Saturation
5) End tidal carbon dioxide-Qualitative estimation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In obese patients undergoing general anaesthesia, during the apneic period mask ventilation was carried out with the two handed CE technique of mask ventilation for a period of 3 minutes. The expired tidal volumes and peak airway pressures were measured for 12 breaths each minute. If unable to mask ventilate the difficult mask ventilation protocol was initiated and patients excluded from study.
Interventions/Control_2
In obese patients undergoing general anaesthesia, during the apneic period mask ventilation was carried out with the VE technique of mask ventilation for a period of 3 minutes. The expired tidal volumes and peak airway pressures were measured for 12 breaths each minute. If unable to mask ventilate the difficult mask ventilation protocol was initiated and patients excluded from study.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
INCLUSION CRITERIA:
o Age group: Above 18-75 years.
o ASA 1/2/3 patients.
o Elective Surgery.
o BMI> 25kg/m2
Key exclusion criteria
EXCLUSION CRITERIA:
o Obstructive and restrictive airway disease.
o Untreated ischemic heart disease/congestive cardiac failure/cardiomyopathy.
o Emergency surgeries.
28
o ASA 4 and above.
o Patients requiring awake intubation.
o Pregnant ladies
o Difficult airway other than overweight and obesity
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Dr Sukanya |
| Middle name | |
| Last name | S |
Organization
Bangalore Medical College and Reserach Institute
Division name
Anaesthesiology - post graduate
Zip code
560002
Address
BMCRI Ladies hostel new tharagupet opposite tippu sultan
TEL
9176714319
sukichillz.28@gmail.com
Public contact
Name of contact person
| 1st name | Sukanya |
| Middle name | |
| Last name | S |
Organization
Bangalore medical college and research institute
Division name
Anaesthesiology - post graduate
Zip code
560002
Address
BMCRI Ladies hostel new tharagupet opposite tippu sultan
TEL
9176714319
Homepage URL
sukichillz.28@gmail.com
Sponsor or person
Institute
Bangalore Medical College and Reserach Institute
Department of Anaesthesiology
Institute
Department
Personal name
Funding Source
Organization
No Funding sources
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
Bangalore medical college and research institute - Institutional Ethics Commitee
Address
BMCRI Ladies hostel new tharagupet opposite tippu sultan
Tel
8610173499
sukichillz.28@gmail.com
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
| 2022 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
https://1drv.ms/w/s!Avf4ls218GMUgwVr051Pc2krUVBy?e=1mrVra
Publication of results
Unpublished
Result
URL related to results and publications
Not published or not presented.
Number of participants that the trial has enrolled
70
Results
The mean expired TV(SD) achieved in V-E technique was 453.88ml + 31.21 and C-E technique was 349.83ml +26.38. The mean PAP(SD) generated in V-E technique was 26.30cmH2O +1.08 and C-E technique was 22.52 cm H2O +1.21. The expired tidal volumes and mean peak airway pressures was statistically significant (p value <0.001) between groups.
Results date posted
| 2022 | Year | 10 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean body mass index in C-E technique group was 33.09 kg/m2 versus The mean body mass index in V-E technique group was 34.01 kg/m2.
12 females and 19 males were included in the C-E technique of mask ventilation group. 14 females and 17 males were included in the V-E technique of mask ventilation group.
Participant flow
In our study we took 70 participants, 8 patients were excluded from the C-E technique of mask ventilation due to difficulty in mask ventilation. In the remaining 62 patients 31 patients each underwent CE and VE techniques respectively. Data recorded and analyzed.
Adverse events
There were no adverse events.
Outcome measures
V-E technique of mask ventilation is better than C-E technique, in delivering higher tidal volume.
Plan to share IPD
No
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 23 | Day |
Last modified on
| 2022 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056139
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