Comprative evaluation of pressure control ventilation and volume control ventilation on intraoperative blood loss in rhinoplasty surgery
Design
This study is a double-blind randomized clinical trial with parallel groups on 30 patients. Block randomization method is used for randomization.
Settings and conduct
First a suitable venous line is taken and the infusion of venous fluids is started, then for premedication, midazolam 20 micrograms per kilogram and fentanyl 3 micrograms per kilogram are prescribed. Induction of anesthesia is performed in the same way in both groups. Patients are intubated with a spiral tube and subjected to mechanical ventilation. In the group of patients under mechanical ventilation with volume ventilation mode, the tidal volume is 7 ml per kg and the number of breaths is 10 times per minute and the ratio of inhalation to exhalation is 1: 2. In the pressure ventilation group with pressure mode, patients are exposed to a respiratory pressure of 15 cm of water and 10 breaths per minute, and gradually the pressure changes to reach EtCO2 = 40-35. All patients are operated on by a surgeon. Comparison indicators are then recorded and measured. This study is performed in Rasoul Akram Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient satisfaction; candidate for rhinoplasty surgery.
Exclusion criteria: body mass index higher than 35; coagulation disorders.
Intervention groups
Intervention group: patients undergoing rhinoplasty surgery who, after anesthesia, use volume mode to give respiratory volume to the patient. Control group: patients undergoing rhinoplasty surgery who, after anesthesia, use pressure mode to give respiratory volume to the patient.
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprative evaluation of pressure control ventilation and volume control ventilation on intraoperative blood loss in rhinoplasty surgery .
Public title
The effect of respiratory system on reducing bleeding in rhinoplasty surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction
Candidate for rhinoplasty surgery
Exclusion criteria:
Pregnancy
Body mass index higher than 35
Coagulation disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.
To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit.
Here, based on the block, we divide 4 people into groups.
1. TTCC 2. TCTC 3. TCCT
4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of outcomes do not know about the treatment process and study groups, and information is provided to them in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-11-30, 1400/09/09
Ethics committee reference number
IR.IUMS.FMD.REC.1400.517
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
Y81
ICD-10 code description
General- and plastic-surgery devices associated with adverse incidents
Primary outcomes
1
Description
Bleeding rate
Timepoint
During the surgery
Method of measurement
Number of blood gases and volume of blood inside the suction
2
Description
Surgeon satisfaction
Timepoint
During the surgery
Method of measurement
Using the Likert scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
During surgery
Method of measurement
Using monitor
2
Description
Heart rate
Timepoint
During surgery
Method of measurement
Using monitor
Intervention groups
1
Description
Intervention group: First, a suitable venous line is taken and then premedication is prescribed. Induction of anesthesia of patients is performed by the same method in both groups. Then, the patients are intubated with a spiral tube made by Jahan Tajhiz Hakim Company and subjected to mechanical ventilation. In the intervention group, patients are mechanically ventilated with a volume ventilation mode with a current volume of 7 ml per kg and a rate of respiration of 10 per minute and a ratio of inhalation to exhalation of 1: 2. All patients are operated on by a surgeon. During surgery, the patient's bleeding rate was checked by checking the number of blood-soaked gases and the content of the suction, the surgeon's satisfaction was measured using the Likert scale, and the bleeding in the surgical field was measured using the Boezaart criterion at the end of the operation. The anesthesia device used for respiratory ventilation is the Fabius plus SW 3.n model.
Category
Treatment - Devices
2
Description
Control group: First, a suitable venous line is taken and then premedication is prescribed. Induction of anesthesia of patients is performed by the same method in both groups. Then, the patients are intubated with a spiral tube made by Jahan Tajhiz Hakim Company and subjected to mechanical ventilation. In the pressure ventilation group with pressure mode, patients are exposed to a respiratory pressure of 15 cm of water and 10 breaths per minute, and gradually the pressure changes to reach EtCO2 = 40-35. All patients are operated on by a surgeon. During surgery, the patient's bleeding rate was checked by checking the number of blood-soaked gases and the content of the suction, the surgeon's satisfaction was measured using the Likert scale, and the bleeding in the surgical field was measured using the Boezaart criterion at the end of the operation. The anesthesia device used for respiratory ventilation is the Fabius plus SW 3.n model.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Masood Mohseni
Street address
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
mohseni@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 5503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
mohseni@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1446513131
Phone
+98 21 6435 2326
Email
mohseni@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1446513131
Phone
+98 21 6435 2326
Email
mohseni@med.mui.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