Comparison of pressure controlled versus volume controlled mechanical ventilation on
intraoperative oxygenation parameters of obese patients under laparoscopic Cholecystectomy
The aim of study is to compare pressure controlled versus volume controlled mechanical ventilation on intra-operative oxygenation parameters of obese patients under laparoscopic Cholecystectomy. Obese patients with body mass index 30-40 and age 18-60 yr who has laparoscopic cholecystectomy will have spirometry before surgery. General anesthesia (balanced anesthesia) with standard monitoring will be used. Ventilator and oxygenation parameters will be taken every 15 min. At beginning of controlled ventilation, patients of both groups will ventilate by volume controlled ventilation with tidal volume 8cc/kg and inspiration: expiration (I/E) ratio 1:2 to maintain end expiratory CO2 35-40mmHg. After inducing pneumoperitoneum with intra-abdominal pressure of 10-12 mm Hg, patients will be positioned in 25 degree head up. Fifteen minute after pneumoperitoneum, patients randomly allocate in one of pressure controlled ventilation or volume controlled ventilation ventilator modes. Patients of both groups will have positive end expiratory pressure 5 cmH2O in ventilator setting. After 15 min stabilization of pneumoperitoneum, Arterial blood gas is monitored and repeats every 20 min till end of surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411213915N16
Registration date:2014-12-15, 1393/09/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-15, 1393/09/24
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor for Tabriz University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pressure controlled versus volume controlled mechanical ventilation on
intraoperative oxygenation parameters of obese patients under laparoscopic Cholecystectomy
Public title
Comparison of pressure controlled versus volume controlled mechanical ventilation on
intraoperative oxygenation parameters of obese patients under laparoscopic Cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: obese patients with body mass index 30-40; American society of anesthesiologists class 1-2; age 18-60 yr; without restrictive or obstructive lung diseases.
Exclusive criteria: prediction of extubation failure after surgery; intubation failure with routine practice; can not to maintain and stabilization of ventilatory setting after 30 minutes; inability to maintain adequate end expiratory CO2; change of laparoscopy to open surgery.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2014-08-18, 1393/05/27
Ethics committee reference number
9385
Health conditions studied
1
Description of health condition studied
oxygenation status during laparoscopic colecystectomy
ICD-10 code
T80-T88
ICD-10 code description
Complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Oxygenation and ventilatory parameters
Timepoint
Every 20 min till end of surgery
Method of measurement
Arterial Blood Gases
Secondary outcomes
empty
Intervention groups
1
Description
Group A: Pressure controlled ventilation 15 min after pneumoperituneum
Category
Treatment - Devices
2
Description
Group B: Volume controlled ventilation 15 min after pneumoperituneum
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr Ali Peirovifar
Street address
Golgasht Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor for Tabriz University of Medical Sciences
Full name of responsible person
Dr Farhoodi
Street address
Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor for Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Peirovifar
Position
Associate Professor
Other areas of specialty/work
Street address
Operation room, Emam Reza Hospital, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
peirovifara@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Peirovifar
Position
Associate professor
Other areas of specialty/work
Street address
Operation room, Emam Reza Hospital, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
peirovifara@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)