Protocol summary
-
Study aim
-
To determine the effect of using the mask with an innovative nutritional adaptor on the nutritional status of the patient with COVID-19
-
Design
-
crossover RCT design was employed to achieve the aforementioned objectives. 25 patients will be assigned to Join the study group. The study and control group at the same patient
-
Settings and conduct
-
25 patients infected with coronavirus disease, who were admitted in multicenter of respiratory isolation at Baghdad City. On-randomize Probability sample, two samples in same individual control measure and study trail (e.g. control=1 & study=1)
-
Participants/Inclusion and exclusion criteria
-
Inclusion: *Consent & compliance with all aspects of the study protocol, methods.*Contact male & female patients, who are 18 years old and more at the time of data collection phase*Patient diagnosis covid-19*Intensive care patient*Patient on CPAP mask*Conscious*Adult patient *Male and female.
-
Intervention groups
-
Intervention group: The starting point of the intervention phase will start by applying the mask with an innovative nutritional adapter to respond and try to get mixed food and fluid throughout the adaptor. This step will help the patient to eat without a decrease in oxygen saturation and air leakage.
-
Main outcome variables
-
The patient gets oral feeding successfully
General information
-
Reason for update
-
Sample collection completed
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20211022052840N1
Registration date:
2021-11-05, 1400/08/14
Registration timing:
prospective
Last update:
2022-03-17, 1400/12/26
Update count:
1
-
Registration date
-
2021-11-05, 1400/08/14
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-11-01, 1400/08/10
-
Expected recruitment end date
-
2022-02-01, 1400/11/12
-
Actual recruitment start date
-
2021-11-15, 1400/08/24
-
Actual recruitment end date
-
2022-02-15, 1400/11/26
-
Trial completion date
-
2022-03-01, 1400/12/10
-
Scientific title
-
Effectiveness of using the Mask with innovative Nutrition Adaptor of Continuous Positive Airway Pressure Machine for Patients with Corona Virus Disease
-
Public title
-
sing the Mask with innovative Nutrition Adaptor
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
non-invasive ventilation patients
Exclusion criteria:
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
After randomly dividing the patients of the study into two equal groups, the first group was the application of the CPAP mask (the stander hospital mask ) and the second group was the application of the CPAP mask equipped with the innovative national adapter. This interference continues for 24 hours in which it monitors and records the quantities of calories and proteins that the patient took during the application of the stander hospital mask, and monitors and records the quantities of calories and protein for patients who apply the mask equipped with the innovative nutrition adapter. After the end of the first 24 hours of application, it stops and the stander hospital mask is removed from the group. The first group is replaced with the mask with the innovative nutrition adapter and the mask with the innovative nutrition adapter is stopped for the second group and replaced with the stander hospital mask and it lasts for 24 hours as well, during which the calories and proteins that were given to both groups are measured and recorded (SpO2, HR, RR, and air leakage were measured while removing the stander hospital mask to give food to the patient. Variables were also measured during feeding the patients in the two groups through the innovative nutritional adapter interface. At the end of 48 hours, the measurement was stopped and patients continued to wear the stander hospital mask, according to the center's policy
Actual sample size reached:
25
More than 1 sample in each individual
Actual sample size in each individual:
2
Each individual wears the stander hospital mask for 24 hours and then wears the mask with the innovative nutritional adapter for 24 hours
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
A crossover randomized controlled trial ( RCT )
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
Single-blind: the participants in the study do not know which group they have been allocated to, intervention or control
-
Placebo
-
Not used
-
Assignment
-
Crossover
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-11-02, 1400/08/11
-
Ethics committee reference number
-
3786
Health conditions studied
1
-
Description of health condition studied
-
Oral feeding with an innovation feeding adapter in a CPAP mask
-
ICD-10 code
-
J12.81
-
ICD-10 code description
-
Pneumonia due to SARS-associated coronavirus
Primary outcomes
1
-
Description
-
The patient's ability to take food orally through the innovative nutritional adapter, as the daily requirement was fully provided by calculation according to the recommendations of the ESPEN guide without the influence of variables (spo2, HR, RR, and air leakage).
-
Timepoint
-
Subjects response to then apply the mask with innovation nutritional adapter will be within 24hrs
-
Method of measurement
-
Measuring the patient's ability to eat foods and liquids through the innovative adapter in a CPAP mask with monitoring of variables
Intervention groups
1
-
Description
-
Control group: The researcher monitors participants infected with the Coronavirus and receives the Continuous positive airway pressure (CPAP) for 24 hours to monitor whether the participants were able to remove the mask to take food and the effect of variables (pulse rate(PR), respiratory rate(RR), oxygen saturation(SPO2)and air leakage)when the mask was removed And nutritional deficiencies for participants who cannot remove the mask due to low oxygen saturation
-
Category
-
Treatment - Devices
2
-
Description
-
Intervention group: The starting point begins with placing the Continuous positive airway pressure (CPAP) mask with the innovative Nutritional adapter( feeding connection ) that mask was made by the researcher on the participant instead of the mask currently placed on it. This will help the patient obtain fluids and mixed food without the need to remove the mask through the Nutritional adapter. The participant can suck the mixed fluids and food through a tube that reaches from the feeding cup or syringe feeding to the mouth. The participant will remain on the mask equipped with the innovative Nutritional adapter for 24 hours while monitoring the participant’s ability to take food and liquids without the influence of variables (pulse rate(PR), respiratory rate(RR), oxygen saturation(SPO2)and air leakage) and it is measured if the patient can take the daily requirement of Nutrition and water without affecting the variables. The participants are monitored by the researcher with the help of an anesthesiologist, intensive care, and anesthesia technician
-
Category
-
Treatment - Devices
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
The author of the trial is the funding source
-
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
-
Other
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is 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
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
-
When the data will become available and for how long
-
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
-
To whom data/document is available
-
All the related files will be shared with any scientific interested parties.
-
Under which criteria data/document could be used
-
It may be used after seeking the author's permission and acknowledging his contribution.
-
From where data/document is obtainable
-
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: Omar.thamer1202a@conursing.uobaghdad.edu.iq
-
What processes are involved for a request to access data/document
-
N/V
-
Comments
-
Appreciation and thanks to IRCT members for their efforts in supporting researchers