Comparison of ventilation quality after induction of anesthesia by using two methods of Anatomic Face Mask or Nasal Anatomical Mask in subjects with BMI more than 40
Design
70 patients undergoing surgery with general anesthesia will be divided into two groups. In the first group, ventilation with 100% oxygen is performed for three minutes by anatomical face mask. In the second group, ventilation is done through the anatomical nasal mask .
Settings and conduct
This single-blind clinical trial study was performed in Alzahra Hospital in Isfahan, Iran, during 2019-20. 70 patients were randomly divided into two groups of 35 each, in the first group ventilation with face mask and in the second group with nasal mask and the quality of ventilation was compared in two groups. In this study, mask implementations are performed by the researcher are data collection will be done by another person who is not in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients undergoing elective surgery under general anesthesia. Non inclusion criteria: Patients with obstruction of the nose, clear deformity, or fracture in the case of either acute or chronic pulmonary disease.
Intervention groups
Intervention group 1: ventilation is done by face mask. Intervention group 2: ventilation is done by nasal mask.
Main outcome variables
Volume of sequential exhaustion; Oxygen saturation percentage; Maximum airway pressure; Heart Beat; Systolic blood pressure; Diastolic blood pressure; Mean blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N37
Registration date:2019-11-13, 1398/08/22
Registration timing:registered_while_recruiting
Last update:2019-11-13, 1398/08/22
Update count:0
Registration date
2019-11-13, 1398/08/22
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison ventilation quality by anatomic or nasal mask after induction of general anesthesia in patients with body mass index more than 40
Public title
Comparison of two methods of face or nasal mask in fat patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body Mas Index above 40 kg/m2
Age range between 18-70 years old
Candidate for elective surgery under general anesthesia
Exclusion criteria:
Nasal Obstruction
Clear deformity or fracture of the face
Acute or chronic Pulmonary disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two intervention 1 and intervention 2 groups by using Random Allocation Software.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the face or nasal mask is embedded by the researcher and the data is collected by another person who is not aware of the process of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Department of Anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2017-05-30, 1396/03/09
Ethics committee reference number
IR.MUI.REC.1396.3.304
Health conditions studied
1
Description of health condition studied
Mechanical Ventilation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sequential expiratory tidal volume
Timepoint
2 and 5 minutes after incubation
Method of measurement
Pulse oximeter
2
Description
Percentage of blodd Oxygen Saturation
Timepoint
2 and 5 minutes after incubation
Method of measurement
Pulse oximeter
3
Description
Systolic Blood Pressure
Timepoint
2 and 5 minutes after incubation
Method of measurement
Pulse oximeter
4
Description
Diastolic Blood Pressure
Timepoint
2 and 5 minutes after incubation
Method of measurement
Pulse Oximeter
5
Description
Heart rate
Timepoint
2 and 5 minutes after incubation
Method of measurement
Pulse oximeter
6
Description
Mean Arterial Blood Pressure
Timepoint
2 and 5 minutes after incubation
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
Unability to do ventilation during masking
Timepoint
At the first to 5 minutes of intubation
Method of measurement
Observation
Intervention groups
1
Description
Intervention group 1: In this group, routine ventilation with anatomical face mask and 100% oxygen is performed for three minutes. Ventilation is performed using anesthesia control mode at a volume of 8 cc / kg and speed of 12 min. The mean expiratory tidal volume, mean of SpO2, mean of EtCO2, mean of maximum air way pressure in three consecutive breaths in the second minute after the start of ventilation will be determined and recorded.
Category
Treatment - Devices
2
Description
Intervention group2: In this group ventilation is done through the nasal mask. Ventilation is performed using anesthesia control mode at a volume of 8 cc / kg and speed of 12 min. The mean expiratory flow volume, SpO2 mean, EtCO2 mean, mean maximal airway pressure were measured and recorded in the second minute after the start of ventilation.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Hamid Saryazdi
Street address
Department of Anesthesiology, Alzahra hospital, Sofeh street,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
haji@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Isfahan University of Medical Sciences, َHezar jerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3070
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sajjad Adib
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital, Soffeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
sajjadadib@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Omid Aghadavoudi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital,Soffeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 39962174
Email
aghadavoudi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty, School of Medicine, Isfahan, University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 37928081
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the project is owned by the university, it is not possible to publish its data.