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The comparision of volume control versus pressure control ventilation effects on the mechancal parameters of respiratory system and gas exchange during laparascopic gastric bypass surgeries in obese patients

Protocol summary

Summary
The aim of this study is to compare the effects of two ventilation methods (Pressure VS volume control) on respiratory mechanics, quality of respiratory gases exchange and hemodynamic parameters of morbidly obese patients during laparoscopic bariatric operations. In a single blind randomized clinical trial, 60 patients candidated for laparoscopic bariatric surgery, with inclusion (BMI> 35 and 18 < age < 60 years) and exclusion (ASA class > III, inability of maintaining programed ventilation protocol) criteria will be selected. After anesthesia induction for intraoperative ventilation, patients are to be rolled randomly in volume (VCV) or pressure (PCV) control ventilation groups. The intervention is as follows: In (VCV) group, patients will be ventilated with a tidal volume = 6-8 ml/ ideal BW and RR= 12/min. And in (PCV) group, inspiratory pressure will adjust to be delivered above tidal volume. Respiratory rate (RR) regulation will be used to keep the ET-CO2 between the ranges of 30-40 mmhg. Minute ventilation, exhaled tidal volume, peak and mean airway pressure, hemodynamic variables, peripheral blood oxygen saturation (SPO2), end of tidal CO2, will be recorded 5 min after intraperitoneal CO2 insufflation and then every 15 min during surgery. Arterial blood gas analysis are also to be checked two times with 30 min interval in the same period. Finally, the collected data will be put into evaluation and analysis using proper statistical methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052711398N10
Registration date: 2017-06-20, 1396/03/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-20, 1396/03/30
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, IUMS
Expected recruitment start date
2017-06-06, 1396/03/16
Expected recruitment end date
2017-11-07, 1396/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparision of volume control versus pressure control ventilation effects on the mechancal parameters of respiratory system and gas exchange during laparascopic gastric bypass surgeries in obese patients
Public title
Comparison of volume v/s pressure control ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Body mass index more than 35 kg/m2; 18 < Age < 60; ASA class II- III; Consent for participation in the study Exclusion criteria: 18 > Age > 60; Difficult Intubation; Inability to maintaining stable ventilator setting for 15 min; Inability to maintaining an appropriate ET-CO2; Inability of extubation in the operating room; Change of surgical technique to open surgery; History of sever cardio-pulmonary disease; ASA class > III; Refusal of participation in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Postal code
Approval date
2017-04-21, 1396/02/01
Ethics committee reference number
ir.iums.REC.1396.9411174013

Health conditions studied

1

Description of health condition studied
Morbid obesity
ICD-10 code
E66.8
ICD-10 code description
Other obesity

Primary outcomes

1

Description
Peak airway pressure
Timepoint
Every 15 min
Method of measurement
Anesthesia machine internal sensor

Secondary outcomes

1

Description
Dynamic compliance of respiratory system
Timepoint
Every 15 min
Method of measurement
Calculation by formula

2

Description
Arterial blood oxygenation
Timepoint
Two times with 30 min interval after starting of laparoscopy
Method of measurement
Arterial blood gas analysis

Intervention groups

1

Description
In the intervention group after induction of anesthesia & intubation, patients will be ventilated with pressure control mode. so the pressure will increase until ideal tidal volume (6-8 ml/kg) reached.
Category
Other

2

Description
In control group for mechanical ventilation during anesthesia, volume control mode will be used. Tidal volume set on 6-8 ml/kg of ideal body weight.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mohammad Reza Ghodraty
Street address
Anesthesia ward, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Eftekhar MD.
Street address
Research deputy, Medicine Faculty, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Anesthesiologist, Faculty member
Other areas of specialty/work
Street address
Anesthesia Ward, Firoozghar Hospital, Beh-Afarin St.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
mrghodrati@yahoo.com ghodrati.mr@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Faculty member, Associate Professor
Other areas of specialty/work
Street address
Anesthesia Ward, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
mrghodrati@yahoo.comghodrati.mr@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sinadokht Tavoosian MD.
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Anesthesia Ward, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
sina.tavoosian7@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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