Evaluation of the effect of esophageal pressure measurement for non-invasive positive pressure ventilation (NIPPV) regulation for the prevention of pulmonary barotrauma in comparison with control group in patients with Covid 19 undergoing respiratory support admitted to the intensive care unit
Evaluation of the effect of esophageal pressure measurement for non-invasive positive pressure ventilation (NIPPV) regulation for the prevention of pulmonary barotrauma in comparison with control group in patients with Covid 19 undergoing respiratory support admitted to the intensive care unit
Design
Clinical trial with control group, double-blind, randomized, phase 2 on 90 patients. Randomizer softwere was used for randomization.
Settings and conduct
Patients with Covid 19 admitted to the intensive care unit of Imam Reza Hospital are included in the study and are divided into two groups. The first group is adjusted by measuring the intraesophageal pressure and the second group is adjusted by their non-invasive ventilation settings based on anesthesia instructions. The researcher and statistical analyst do not notice the study groups. Finally, the data are evaluated for their effectiveness in reducing barotrauma.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Covid 19 with positive PCR or CT scan, hospitalized in the intensive care unit, patient is receiving non-mechanical ventilation, patient should be fed through the gastric feeding tube (NG tube)
Intervention groups
Patients are divided into two groups. The first group measures their non-invasive ventilation settings by measuring their intraesophageal pressure; the second group measures their non-invasive ventilation settings based on anesthesia instructions.
Main outcome variables
Baro trauma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200612047740N4
Registration date:2022-06-18, 1401/03/28
Registration timing:prospective
Last update:2022-06-18, 1401/03/28
Update count:0
Registration date
2022-06-18, 1401/03/28
Registrant information
Name
Hossein Naderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3568 5233
Email address
hossein.naderi1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of esophageal pressure measurement for non-invasive positive pressure ventilation (NIPPV) regulation for the prevention of pulmonary barotrauma in comparison with control group in patients with Covid 19 undergoing respiratory support admitted to the intensive care unit
Public title
The effect of esophageal pressure measurement to prevent pulmonary barotrauma in patients with Covid 19 undergoing respiratory support
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Covid 19 with positive PCR or CT scan
Hospitalized in the intensive care unit
Patient is receiving non-mechanical ventilation
Patient should be fed through the gastric feeding tube (NG tube)
Informed consent of the patient or his legal guardian
Exclusion criteria:
Coagulation disorders
Gastrointestinal bleeding
History of fractures and trauma to the base of the skull
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to the groups of A and B using Randomization software (https://www.randomizer.org/) according to inclusion criteria. Each group has 45 members. In this software, numbers from 1 to 90 are entered into the software and at one time, they randomly pick the numbers from one to ninety so that the number of people in each group is equal. The numbers remain hidden and the order in which people enter the study is revealed in the order in which the data output software is displayed, and if the number is between 1 and 45, it is placed in the first group and if it is between 46 and 90, it is placed in the second group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are divided into two groups A and B and are kept in two separate parts. How to do the study for each group is described. The information is collected by the clinical caregiver and the researcher and data analyzer do not know the patient group and after analyzing the data, the codes are decoded to avoid bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical
Street address
AJA university of medical sciences, Shahid Etemadzade st, West Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.AJAUMS.REC.1400.305
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U.07
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
Intra esophageal pressure
Timepoint
Intraesophageal pressure is measured twice daily (morning and evening) while receiving non-invasive ventilation while the patient is in the intensive care unit(ICU)
Method of measurement
Manometer
2
Description
Number of people with barotrauma
Timepoint
From the start of non-invasive ventilation to the onset of barotrauma
Method of measurement
Observe and record
Secondary outcomes
1
Description
Oxygen saturation
Timepoint
It is measured twice daily (morning and evening) while receiving non-invasive ventilation while the patient is in the intensive care unit(ICU).
Method of measurement
Pulse oximeter
2
Description
Duration of stay in the intensive care unit
Timepoint
From the time of entering the intensive care unit until the time of discharge or the time of death
Method of measurement
Observe and record
3
Description
Trans pulmonary pressure
Timepoint
Trans pulmonary pressure is measured twice daily (morning and evening) while receiving non-invasive ventilation while the patient is in the ICU.
Method of measurement
Manometer
4
Description
Time of barotrauma
Timepoint
Number of days from the start of non-invasive ventilation to the onset of barotrauma
Method of measurement
Observe and record
Intervention groups
1
Description
Intervention group: Patients's nasogastric tube is pulled up and connected to a manometer and their intraesophageal pressure is measured. Ventilation settings are adjusted so that the difference in pulmonary pressure remains between 0-10 cm of water and if it is more than 35 to 40 cm of water, the settings of the device are reduced and no trauma occurs. Finally, the incidence of barotrauma in this group is measured.
Category
Prevention
2
Description
Control group: Patients in this group do not have daily intraesophageal pressure measurements. Ventilation settings of patients in this group are controlled through anesthesia instructions set by the anesthesiologist (project manager) and the incidence of barotrauma in this group is measured.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mohammadreza Rafiee
Street address
Shahid Etemadzade st, West Fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
hossein.naderi1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Mojtaba Yousefi
Street address
Shahid Etemadzade st, West Fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
research@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Hossein Naderi
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
AJA University of medical sciences, Shahid Etemadzade st, West Fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Fax
Email
hossein.naderi1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hossein Naderi
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
AJA University Of Medical Sciences, Shahid Etemadzade st, West Fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 31 3568 5233
Fax
Email
hossein.naderi1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hossein Naderi
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
AJA University Of Medical Sciences, Shahid Etemadzade st, West Fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 31 3568 5233
Fax
Email
hossein.naderi1374@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only registered symptoms can be published without mentioning the names of the participants
When the data will become available and for how long
Start of access period 6 months after printing the results up to one year after printing
To whom data/document is available
Only available to scholars working in academia and academia
Under which criteria data/document could be used
Written request via email(hossein.naderi1374@gmail.com) and university approval
From where data/document is obtainable
By contacting the corresponding author
What processes are involved for a request to access data/document
After the email is received by the applicant, it takes one week to agree The university will be obtained and then will be notified to the requestor. Maximum of this process takes ten days.