Investigating the effect of different levels of positive end-expiratory pressure on hemodynamic parameters in patients candidates for laparoscopic cephalocystectomy
Investigating the effect of different levels of positive end-expiratory pressure on hemodynamic parameters in patients who are candidates for laparoscopic cholecystectomy.
Design
This randomized clinical trial with crossover groups will be conducted on 50 patients referred to Mohammadi Bandar Abbas Hospital who undergo laparoscopic cephalocystectomy surgery. Patients participating in the study will be divided into two groups by means of randomized blocks.
Settings and conduct
Patients referred to Mohammadi Bandar Abbas Hospital who undergo laparoscopic head cystectomy will be included in the study. Patients participating in the study will be randomly assigned to two groups using blocks of sizes 4, 6, and 8.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients undergoing laparoscopic cholecystectomy who consent to participate in the study.Exclusion criteria: It includes patients who have heart and lung problems
Intervention groups
Intervention group 1: they are subjected to mechanical ventilation with a positive end-exhalation pressure of 0 to 8 cm. Intervention group 2: will be subjected to mechanical ventilation without positive end-expiratory pressure.
Main outcome variables
Hemodynamic symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190528043737N4
Registration date:2024-05-21, 1403/03/01
Registration timing:prospective
Last update:2024-05-21, 1403/03/01
Update count:0
Registration date
2024-05-21, 1403/03/01
Registrant information
Name
Mehrdad Malekshoar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
mehrdad.malekshoar@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-10-31, 1403/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of different levels of positive end-expiratory pressure on hemodynamic parameters in patients candidates for laparoscopic cephalocystectomy
Public title
The effect of different levels of positive end-expiratory pressure on hemodynamic parameters in laparoscopic cholecystectomy candidates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Anesthesia class one and two
general anesthesia
Exclusion criteria:
Severe heart failure
Respiratory failure
Asthma
Chronic obstructive pulmonary disease
Age
From 17 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used, with blocks of sizes 4, 6, and 8 in 20 blocks, people will be randomly assigned to two groups.
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
Ethics committee of Bandare-abbas University of Medical Sciences
Street address
Bandar Abbas University of Medical Sciences, Shahid Chamran Boulevard,Bandar Abbas
City
Bandare-abbas
Province
Hormozgan
Postal code
7914964157
Approval date
2024-04-05, 1403/01/17
Ethics committee reference number
IR.HUMS.REC.1403.021
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy
Primary outcomes
1
Description
Hemodynamic symptoms
Timepoint
30 minutes after intubation, extubation and recovery
Method of measurement
Monitoring
2
Description
Capnography
Timepoint
30 minutes after intubation
Method of measurement
Capnograph
3
Description
Heart beat
Timepoint
30 minutes after intubation, extubation and recovery
Method of measurement
Monitoring
4
Description
Arterial blood gases
Timepoint
30 minutes after intubation, extubation and recovery
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The patient is subjected to mechanical ventilation with specifications TV=6-8cc/kg, RR=12-14 b/m, inspiratory/expiratory ratio=1/2-1/3 and PEEP=0-8cmH2O
Category
Other
2
Description
Control group: the patient is subjected to mechanical ventilation with specifications TV=6-8cc/kg, RR=12-14 b/m, ratio=1/2-1/3 inspiratory/expiratory
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Majid Vatankhah
Street address
Shahid Chamran Blvd, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
majid.vatnkhah123@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Vatankhah
Street address
Shahid Chamran Blvd, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
majid.vatnkhah123@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Vatankhah
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas, Shahid Chamran Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
majid.vatnkhah123@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Vatankhah
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Blvd, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
majid.vatnkhah123@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Vatankhah
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Blvd, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
majid.vatnkhah123@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available