Effectiveness of using the Mask with innovative Nutrition Adaptor of Continuous Positive Airway Pressure Machine for Patients with Corona Virus Disease
To determine the effect of using the mask with an innovative nutritional adaptor on the nutritional status of the patient with COVID-19
Design
A quasi-experimental comparative 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. Exclusion:* Dysphagia*Panic attack
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.
Main outcome variables
The patient gets oral feeding successfully
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211022052840N1
Registration date:2021-11-05, 1400/08/14
Registration timing:registered_while_recruiting
Last update:2021-11-05, 1400/08/14
Update count:1
Registration date
2021-11-05, 1400/08/14
Registrant information
Name
Omar AL-Ghrairi
Name of organization / entity
University of Baghdad, College of Nursing
Country
Iraq
Phone
+964 1 521 1495
Email address
omar.thamer1202a@conursing.uobaghdad.edu.iq
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
empty
Actual recruitment end date
empty
Trial completion date
empty
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
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patient diagnosis covid-19
Intensive care patient
Patient on CPAP
Conscious
Adult patient
Male and female
Exclusion criteria:
Dysphagia
Panic attack
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
The patient wears the mask of CPAP for 24 hours and monitors the variables (Oxygen saturation (SPO2), Pulse rate (P.R), Respiratory Rate (R.R) , Air Leakage)during get the nutrition then wear the Mask with an innovative Nutrition Adaptor for 24hrs and get nutrition according to the patient need and monitor the variables ((SPO2, P.R, R.R and Air Leakage)
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muaadham
City
Baghdad
Postal code
10001
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
Oral feeding with an innovation feeding adapter in a CPAP mask
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
Secondary outcomes
empty
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
N/A
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
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
multicenter of respiratory isolation at Medical City Complex
Full name of responsible person
Omar AL.Ghrairi
Street address
Bab AL-Muaadham
City
Baghdad
Postal code
10001
Phone
+964 1 415 0077
Email
Omar.thamer1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Huda Baqer Hassan, PhD. Dean
Street address
Bab AL-Muaadham campus
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
Omar.thamer1202a@conursing.uobaghdad.edu.iq
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
Person responsible for general inquiries
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Omar AL.Ghrairi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
ICU
Street address
Bab AL-Muaadham campus
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
Omar.thamer1202a@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Huda Baqer Hassan, PhD. Dean
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
ICU
Street address
Bab AL-Muaadham campus
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
Omar.thamer1202a@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Omar AL.Ghrairi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
ICU
Street address
Bab AL-Muaadham campus
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
Omar.thamer1202a@conursing.uobaghdad.edu.iq
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