NCT05309239

Brief Summary

evaluation of ROX index among ICU patients to evaluate the success of non invasive ventilation or the need for intubation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 21, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 25, 2022

Last Update Submit

March 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Success vs failure of non invasive ventilation

    by ROX index calculation

    within 6 months

Interventions

observation of ROX index to evaluate the efficacy of non invasive ventilation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients administered in chest ICU in Assiut university hospital

You may qualify if:

  • Participants admitted to RICU with type I and type II respiratory failure requiring NIV support with one or more of the following :
  • PaO2/FiO2 less than or equal to 300 mmHg despite supplying oxygen at a flow rate ≥ to 10 l/min for ≥ 15 min
  • Patients requiring ventilatory support due to increased respiratory rate ≥ 25 breaths/min or using accessory muscles of respiration

You may not qualify if:

  • \. Absolute indication for intubation like coma, hemodynamic instability, or life-threatening arrhythmia.
  • \. Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy,or active upper gastrointestinal bleeding.
  • \. Resusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Central Study Contacts

Kholoud zakaria mahmoud, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kholoud Zakaria

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 4, 2022

Study Start

March 21, 2022

Primary Completion

April 1, 2023

Study Completion

March 1, 2024

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations