Protocol summary
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Study aim
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Comparison of the effect of two ventilation methods with volume and pressure control on gas exchanges and mechanical variables of the respiratory system during obesity surgery.
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Design
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A randomized crossover single blind clinical trial, which 26 patients are divided randomly in two groups of 13. The study is in phase 3 trial and simple random allocation (lottery) is used for randomization.
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Settings and conduct
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This study is doing in Firoozgar teaching hospital. After induction of general anesthesia, in the first group, patients primarily will be put under volume control ventilation mode, which continue until 15 minutes after start of surgery and gas insufflation into the abdominal cavity, then ventilation changes to pressure control mode until the end of the operation. In second group ventilation start with pressure mode and then will be changed to volume mode same as the above mentioned manner. Patients and person who analyzing data will be blinded into intervention used in each patient.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with body mass index between 40 and 55; Age over 18 years.
Exclusion criteria: Patient dissatisfaction; History of severe respiratory diseases; History of advanced cardiovascular diseases.
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Intervention groups
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In the first group after induction of anesthesia, pulmonary ventilation begins with volume mode and continues until 15 minutes after gas is blown into the abdomen, then the mode of ventilation will be changed to pressure control mode til the end of surgery. In second group in opposite to the first group, primarily from pressure mode ventilation and then volume mode will be used as above mentioned arrangement.
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Main outcome variables
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O2saturation; Peak airway pressure; Arterial blood gas analysis; End tidal PCo2; Pulmonary dead space volume; Dynamic pulmonary compliance; Alveolar to arterial O2 pressure gradient.
General information
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Reason for update
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Record the realized time of the beginning of the patient recruitment and insert the time of the end of the trial.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121107011398N14
Registration date:
2020-05-04, 1399/02/15
Registration timing:
registered_while_recruiting
Last update:
2021-12-19, 1400/09/28
Update count:
1
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Registration date
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2020-05-04, 1399/02/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-20, 1397/12/29
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Expected recruitment end date
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2020-09-19, 1399/06/29
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Actual recruitment start date
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2020-04-29, 1399/02/10
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Actual recruitment end date
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2020-12-20, 1399/09/30
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Trial completion date
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2020-12-20, 1399/09/30
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Scientific title
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The comparison of two volume and pressure control ventilation modes on the gas exchange and mechanical parameters of respiratory system during laparoscopic bariatric surgeries, a cross over clinical trial.
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Public title
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Comparison of two volume and pressure control ventilation modes during laparoscopic bariatric surgeries.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Obese patients candidated for bariatric surgeries with body mass index (BMI) 40-55
Patients older than 18 and lower than 60 years
ASA physical class < or = class III
Exclusion criteria:
Patient dissatisfaction
History of sever respiratory disease
History of advanced cardiovascular disease
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
26
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This is a randomized clinical trial in which patients are assigned to one of two study groups using simple randomization methods in order of their entry. The randomization unit is personal and using a lottery drawing method, the third person draws blindly a sealed paper on which one of two groups' names is written. Thus we could achieve a concealed random sequence for allocation of patients as the process of lottery is repeated for each new patient entered.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Due to the fact that the general anesthesia study is performed, the participating patients do not know the group and type of intervention. There is no possibility of blinding the person who intervenes and records the outcomes.
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-22, 1398/04/01
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Ethics committee reference number
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IR.IUMS.FMD.REC.1398.150
Health conditions studied
1
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Description of health condition studied
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Obesity
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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O2 saturation (SPo2)
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Timepoint
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Every 5 min during surgery
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Method of measurement
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With Pulse Oximeter
2
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Description
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End-tidal Co2
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Timepoint
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Every 5 min during surgery
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Method of measurement
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With Capnograph
3
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Description
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Peak airway pressure
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Timepoint
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Every 5 min during surgery
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Method of measurement
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By the monitor of anesthesia machine
4
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Description
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Arterial blood gas analysis
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Timepoint
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In 15 and 30 minutes after insufflation of gas into abdominal cavity.
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Method of measurement
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By sending arterial blood sample to laboratory.
Secondary outcomes
1
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Description
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Exhaled tidal volume
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Timepoint
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During Surgery
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Method of measurement
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By anesthesia machine
2
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Description
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Dynamic pulmonary compliance
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Timepoint
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Every 5 min during surgery
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Method of measurement
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Calculation of variable by using the amounts of airway pressure and tidal volume
3
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Description
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Respiratory dead space
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Timepoint
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Every 5 min during surgery
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Method of measurement
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Calculation by the use of arterial and end tidal PCo2 pressure
Intervention groups
1
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Description
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The study protocol being a crossover, each participating patient will receive both types of interventions. The main intervention in the study is the pressure controlled mode of mechanical ventilation during bariatric surgery and its comparison with standard (volume controlled) ventilation. For this purpose, the participating patients were randomly divided into to groups: in the first group and after the induction of anesthesia, the patients were subjected to volume controlled mode and by 15 minutes after the commencement of the surgery, and intra-abdominal CO2 insufflation, the pressure controlled mode is applied. [volume control and then pressure control (VC-PC)]. For the pressure controlled mode, the ventilator is adjusted as follows: airway pressure 20 cmH2O, respiratory rate of 12 per minute. The airway pressure is progressively increased to reach the ideal tidal volume (6-8 cc/kg of ideal body weight). On the other hand, for the volume-controlled mode, the ventilator is adjusted on 7 cc/kg of ideal body weight. For both methods, the respiration rate module is used to keep the end tidal CO2 rate at 35-40 mmHg.
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Category
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Treatment - Other
2
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Description
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Control group: In second group the selection of ventilation mode is in opposite to the first group [Pressure control - Volume Control (PC-VC)]. The EDP-Neptune MEDEC BENELUX NV (BELGIUM) anesthesia machine and its ventilator were used for ventilation during anesthesia for both ventilation modes
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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The personal information of the participants in the study is confidential and there is no need to publish it.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Informed consent, Study protocol and details of methodology, Data files (SPSS) without specifying personal information, Data analysis tables and outputs.
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When the data will become available and for how long
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After completing the study and defending the residency thesis and sending the article to the journals for publication.
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To whom data/document is available
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Researchers and students interested in the subject, university and ministry officials, the magazine's editor-in-chief.
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Under which criteria data/document could be used
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Use to design additional studies, verification by officials and managers of journals.
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From where data/document is obtainable
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Corresponding author
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What processes are involved for a request to access data/document
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Request via official letter or email
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Comments
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