Evaluation the effect of mechanical ventilation with a tidal volume of 10 ml / kg and 6 ml / kg during abdominal cancer surgery on the rate of compliance and airway resistance of patients
The aim of this study was to evaluate the rate of airway compliance and resistance in abdominal cancer surgery and compare two groups receiving high current volume of 10 mL / kg and low current volume of 6 mL / kg.
Design
Interventional study with a control group of parallel, randomized, double-blind Phase 3 using the table of random numbers that were performed on 80 patients
Settings and conduct
This study was performed on 90 patients with upper and lower gastrointestinal cancers referred to Imam Reza Hospital in Mashhad, who were randomly divided into intervention and control groups. The first group of patients underwent ventilation with a volume of 10 ml / kg and the number of breaths is 8 (peep = 5), and the second is mechanically ventilated with a volume of 6 mL / kg and a number of breaths of 14. The effect of this intervention is evaluated before and 2 hours after the operation using the mentioned criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients aged 20-65 years who are candidates for elective abdominal surgery due to cancer and non-admission conditions for diseases such as chronic lung diseases like asthma and heart
Intervention groups
In control group, after anesthesia in abdominal cancer surgery .Mechanical ventilation is performed with positive end-expiratory pressure (number of breaths 14 with Peep = 5) and low volume at 6 ml / kg and intervention group Mechanical ventilation is performed with positive end-expiratory pressure (number of breaths 8 with Peep = 5) and high volume at 10 ml / kg
Main outcome variables
Compliance and airway resistance in abdominal cancer surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N35
Registration date:2020-12-28, 1399/10/08
Registration timing:registered_while_recruiting
Last update:2020-12-28, 1399/10/08
Update count:0
Registration date
2020-12-28, 1399/10/08
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of mechanical ventilation with a tidal volume of 10 ml / kg and 6 ml / kg during abdominal cancer surgery on the rate of compliance and airway resistance of patients
Public title
The effect of mechanical ventilation during abdominal cancer surgery in improving pulmonary complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for elective abdominal surgery due to cancer
People in the age range of 65-65 years
Exclusion criteria:
Other diseases such as chronic lung disease like asthma and COPD and heart disease or kidney failure
Existence of other concomitant surgeries such as thoracic surgery
History of previous lung surgery
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are not aware of the intervention. Also, outcome assessors are unaware of how patients are grouped, although patients are aware of the project after receiving full explanations and even an invitation from the patients' families, but they do not know which group they are in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreishi building
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.519
Health conditions studied
1
Description of health condition studied
abdomen cancer
ICD-10 code
D21.4
ICD-10 code description
Benign neoplasm of connective and other soft tissue of abdomen
Primary outcomes
1
Description
Compliance rate
Timepoint
At the beginning of the study (before the intervention) and 2 hours after the surgery
Method of measurement
Ventilator
2
Description
Airway resistance
Timepoint
At the beginning of the study (before the intervention) and 2 hours after the surgery
Method of measurement
Ventilator
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, after anesthesia in abdominal cancer surgery and manual ventilation with a mask 8-10 times per minute and passed 2 minutes when the patient's jaw is relaxed the patient is intubated and after confirmation of the patient's tube Correct location, ventilation or auxiliary mechanical ventilation for the patient is done. Mechanical ventilation is performed with a positive end-expiratory pressure (8 breaths = 5 peeps) and a high current volume of 10 ml / kg. Mechanical ventilation is an essential support method for maintaining adequate gas exchange during general anesthesia, which prevents postoperative complications, hypoxemia, and improves lung function.
Category
Prevention
2
Description
Control group: In this group, after anesthesia in abdominal cancer surgery and manual ventilation with a mask 8-10 times per minute and after 2 minutes when the patient's jaw is relaxed, the patient is intubated and after confirmation of the patient's tube Correct location ventilation or auxiliary mechanical ventilation for the patient is done.Mechanical ventilation is performed with positive end-expiratory pressure (number of breaths 14 with Peep = 5) and low volume at 6 ml / kg
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Rahele Nejati
Street address
Ebne Sina St. Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
Nejatir2@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ebne Sina St., Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
RazaviM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ebne Sina St., Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
RazaviM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ebne Sina St., Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
RazaviM@mums.ac.ir
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