High Flow Nasal Therapy in Covid 19 Patient

Predictors of Success of High Flow Nasal Therapy in Covid 19 Patients

This study aims to To identify factors that predict success of high flow nasal therapy in covid19 patients .

Study Overview

• Status: Not yet recruiting
• Conditions: High Flow Nasal Therapy
• Intervention / Treatment: Other: high flow nasal therapy

Detailed Description

Coronavirus disease 2019 (COVID-19) is a potentially fatal infection caused by the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)[1]. The highly contagious nature and exponential spread of SARS-CoV-2, coupled with its potential for a rapid progressto acute respiratory distress syndrome (ARDS), has overwhelmed health care systems globally, contributing to the high mortality rates in early reports [1,2].

The initial approach for respiratory support for severe COVID-19 pneumonia centredaround invasive mechanical ventilation and the standard lung protective strategy recommended for ARDS[3]. This may have been detrimental to a proportion of patients due to ventilator induced lung injury (VILI) and associated systemic inflammation[4]. Furthermore, other strategies to improve oxygenation may be more appropriate in patients with hypoxemic respiratory failure who do not require ventilatorysupport[4].

High-flow nasal oxygen (HFNO) is delivered by an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal interface.

It delivers adequately heated and humidified medical gas at flow-rates of up to 60L/min, and is considered to have a number of physiological benefits, including the reduction of anatomical dead space and work of breathing, the provision of a constant fraction of inspired oxygen with adequate humidification and a degree of positive end-expiratory pressure (PEEP) [5,6].

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Maha Mahmoud; Phone Number: 01063453193; Email: maha.mahmoud.1994@gmail.com
• Study Contact Backup: Name: samiaa sadik; Phone Number: 01006769597; Email: samiaa_sadek@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. demographic data including age, sex, smoking history, educational level.
2. Duration of illness before admission, clinical presentation, presence of co morbidities, BMI.
3. Vital signs, and radiologic findings
4. ABG at admission and (half an hour, 2hr, 24 hr, and 48hr)later on.
5. SPO2, FIO2, and respiratory rate at admission for calculating ROX index (SPO2/FIO2)/RR.
6. GCC, and APACHI score at time of admission.
7. Inflammatory markers at time of admission (CBC with differential, CRP, ferritin, D dimer, LDH), in addition to liver and renal function.

At the end of the study patients will be claccifiedin to two groups based on success of high flow nasal therapy:

Group A Covidpatient Who pass on high flow nasal therapy Group B Covidpatient who failed on nasal therapy and need NIV

Description

Inclusion Criteria:

• All Patients above 18 y old that will be diagnosed as COVID 19 based on PCR testing, who fulfil criteria that indicate need for high flow nasal therapy.

Exclusion Criteria:

• o Children less than 18 y old

  • Oropharyngeal and Nasopharyngeal swap negative patients
  • Patients who will refuse inclusion in the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A; Covidpatient Who pass on high flow nasal therapy	Other: high flow nasal therapy; effect of high flow nasal therapy in covid 19 patients who pass and who need non invasive
group B; Covidpatient who failed on high flow nasal therapy and need NIV	Other: high flow nasal therapy; effect of high flow nasal therapy in covid 19 patients who pass and who need non invasive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predictors of success of high flow nasal therapy in covid 19 patients	This study aims to To identify factors that predict success of high flow nasal therapy in covid19 patients	Baseline

Collaborators and Investigators

• Sponsor: Maha Mahmoud Ahmed

Publications and helpful links

General Publications

• Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): September 30, 2022

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (ACTUAL): October 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: nasal therapy in covid patient

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No