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IRCT20211022052840N1 IRCT 2021-11-05 College of Nursing, University of Baghdad sing the Mask with innovative Nutrition Adaptor Effectiveness of using the Mask with innovative Nutrition Adaptor of Continuous Positive Airway Pressure Machine for Patients with Corona Virus Disease 2021-11-01 anticipated 25 Complete https://irct.ir/trial/59623 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: A crossover randomized controlled trial ( RCT ), Blinding description: Single-blind: the participants in the study do not know which group they have been allocated to, intervention or control. N/A Oral feeding with an innovation feeding adapter in a CPAP mask. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: 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: All the related files will be shared with any scientific interested parties. Conditions: It may be used after seeking the author's permission and acknowledging his contribution. Where to obtain: 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 How to obtain: N/V Comments: Appreciation and thanks to IRCT members for their efforts in supporting researchers
public Omar AL.Ghrairi
Bab AL-Muaadham campus
Baghdad Iraq 10001 +964 1 521 1494 Omar.thamer1202a@conursing.uobaghdad.edu.iq College of Nursing, University of Baghdad scientific Professor Huda Baqer Hassan, PhD. Dean
Bab AL-Muaadham campus
Baghdad Iraq 10001 +964 1 521 1494 Omar.thamer1202a@conursing.uobaghdad.edu.iq College of Nursing, University of Baghdad Iraq non-invasive ventilation patients 18 years no limit Both J12.81 Pneumonia due to SARS-associated coronavirus Treatment - Devices Treatment - Devices 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 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 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. The author of the trial is the funding source Approved 2021-11-02 Research Ethical Approval Committee, at the College of Nursing Bab AL-Muaadham Baghdad Baghdad Iraq