Comparative evaluation of the effects of three different recruitment maneuvers during laparoscopic Bariatric surgeries of morbid obese patients on cardiopulmonary Indices
Laparoscopic bariatric surgeries in morbid obese patients may be associated with atelectasis, hypercapnia and hypoxemia, intra and postoperatively. Several strategies are used for prevention of these consequences. This study is going to examine the effects of three different recruitment maneuvers comparatively during surgery and the influence of the maneuvers on some cardiopulmonary Indices. In a Clinical trial, 90 subjects of Laparoscopic surgery with body mass indexes (BMI) higher than 40 randomly divide into 3 equal groups. The first group subject to 10 cmH2O positive end expiratory pressure (PEEP) during surgery, the second group, after venting the pneumoperitoneum, take 5 deep breaths with positive pressure of 40 cmH2O and a 5-second pause and a 5-second Interval (Expiration) and the third group, take both. Pulmonary and hemodynamic parameters will measure every 15 minutes and compare between three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070316415N6
Registration date:2017-07-25, 1396/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-25, 1396/05/03
Registrant information
Name
Mohammad Golparvar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 1750
Email address
golparvar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-08-01, 1395/05/11
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effects of three different recruitment maneuvers during laparoscopic Bariatric surgeries of morbid obese patients on cardiopulmonary Indices
Public title
Effects of recruitment maneuvers on cardiopulmonary indices during laparoscopic bariatric surgeries of morbid obese patients
Purpose
Supportive
Inclusion/Exclusion criteria
Age 15-65 years old; ASA 1 and 2; BMI ≥ 40; no smoking; normal Intra cranial pressure; no pulmonary disease.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan,
First group: patients received 10 cmH2O PEEP from the beginning to the end of the surgery.
Category
Treatment - Other
2
Description
Second group: patients were received 5 breaths with positive pressure of 40 cmH2O with 5 seconds of pauses and 5 second intervals as expiration at the end of surgery and after venting pneumoperitoneum.
Category
Treatment - Other
3
Description
Third group: patients received 10 cmH2O PEEP from the beginning to the end of the surgery and after venting the abdomen patients were received 5 breaths with positive pressure of 40 cmH2O with 5 seconds of pauses and 5 second intervals as expiration
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Center
Full name of responsible person
Golparvar M. MD
Street address
Department of Anesthesia, Alzahra Medical center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ali M Sabzghabaee
Street address
Research manager office, Deputy of research and technology, Isfahan University of Medical Sciences; Hezarjarib Boulevard, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar M MD
Position
Professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of Anesthesia, Alzahra Medical center, Sofeh boulvard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3220 1750
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Professor of Anesthesia and critical Care Group
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3220 1750
Fax
Email
golparvar@med,mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Professor of Anesthesia and critical Care Group
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3220 1750
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)