NCT05094648

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

October 25, 2021

Last Update Submit

October 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

group A

Covidpatient Who pass on high flow nasal therapy

Other: high flow nasal therapy

group B

Covidpatient who failed on high flow nasal therapy and need NIV

Other: high flow nasal therapy

Interventions

effect of high flow nasal therapy in covid 19 patients who pass and who need non invasive

group Agroup B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • o Children less than 18 y old
  • Oropharyngeal and Nasopharyngeal swap negative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27016353BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 25, 2021

First Posted

October 26, 2021

Study Start

November 1, 2021

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

October 26, 2021

Record last verified: 2021-10