The effect of PI max(maximum inspiratory pressure) on respiratory tract complications in patients under laparascopic bariatric surgeries
Design
Fifty fore patients undergoing bariatric surgery were randomly divided into two groups of 27 each in the first group mechanical ventilation will be done with Positive end-expiratory pressure and in the second group without Positive end-expiratory pressure. Patients were randomly allocated into two groups with and without PEEP.
Settings and conduct
This study is a double blind study done in Al-Zahra Hospital in Isfahan during 2019. Patients and data collectors are unaware of the mechanism of mechanical breathing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing barbaric surgery, age range of 18 to 55 years.
Not inclusion criteria: patients with concomitant diseases, especially heart disease such as asthma, emphysema, chronic bronchitis, bronchitis, and pulmonary artery hypertension.
Intervention groups
Intervention group 1: mechanical ventilation volume control based on weight (Tidal Volume = 8 cc/kg)
Intervention group 2: Volume control mechanical ventilation with PEEP = 10 and 100% oxygen at 5 liters per minute
Main outcome variables
Length of stay in Intensive Care Unit (ICU), length of stay in ward, spo2, maximal airway pressure, heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N38
Registration date:2020-01-30, 1398/11/10
Registration timing:retrospective
Last update:2020-01-30, 1398/11/10
Update count:0
Registration date
2020-01-30, 1398/11/10
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
2017-09-22, 1396/06/31
Expected recruitment end date
2018-09-20, 1397/06/29
Actual recruitment start date
2018-09-22, 1397/06/31
Actual recruitment end date
2019-06-19, 1398/03/29
Trial completion date
2019-06-19, 1398/03/29
Scientific title
The effect of PI max on respiratory tract complications in patients under laparascopic bariatric surgeries
Public title
The Effect of Expiry End Air Pressure on Respiratory Complications of Patients Undergoing Gastric Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient candidate for bariatric surgery
Range age between 18 to 55 years
Patient recruitment to participate in the study
Exclusion criteria:
Suffer to cardiovascular diseases
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
54
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients into two groups is done by using "Random Allocation Software". So that in terms of number of samples, the range is inserted into the software. Then the number of groups and the proportion of individuals in each group are determined. The software output is a two-part list with the first part of the number assigned randomly to group one, and the second list is the number assigned to the second group. According to the above list, patients are divided into two groups according to the time of entered to the study and continued until to reach of the required sample size in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind study. So that patients are aware of the mechanical ventilation they receive. The type of mechanical ventilation applied to the patient, including mechanical ventilation with PEEP and mechanical ventilation without PEEP, is performed for the patient, but the person collecting the data will be unaware about the type of mechanical ventilation applied.
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
Vice chancellor for research, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-06-23, 1397/04/02
Ethics committee reference number
IR.MUI.MED.REC.1397.083
Health conditions studied
1
Description of health condition studied
Bariatric surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Respiratory Disorders
Timepoint
During and the end of surgery
Method of measurement
Pulse Oximeter
2
Description
Tidal Volume
Timepoint
During and the end of surgery
Method of measurement
Pulse Oximeter
3
Description
Blood Pressure
Timepoint
During and the end of surgery
Method of measurement
Pulse Oximeter
4
Description
Heart Bit
Timepoint
During and the end of surgery
Method of measurement
Pulse Oximeter
5
Description
stands for peripheral capillary oxygen saturation
Timepoint
During and the end of surgery
Method of measurement
Pulse Oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, the mechanical ventilation of patients will be done based on the ideal weight of patients and tidal volume without applying Psitive End Expiratory Ventilation .
Category
Treatment - Devices
2
Description
Intervention group 2:In this group, the mechanical ventilation of patients will be done based on the ideal weight of patients and tidal volume with applying Positive End Expiratory ventilation and flow rate of 100% oxygen with 5 liters per minute.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
َAlzahra hospital
Full name of responsible person
Heidar Karimi
Street address
Alzahra hospitail, Soffeh street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
heidarkarimi1975@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Department of anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
sajedi@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
Heidar Karimi
Position
Resident of anethesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Alzaha hospital, Soffeh street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
heidarkarimi1975@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parvin Sajedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 36685555
Email
sajedi@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, Heza Jerib street,
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
The plan belongs to the state agency and cannot be shared.