ROX Index in Acute Respiratory Failure

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05309239
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 23.4
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rox Index	Other: ROX index

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Role of ROX Index as an Indicator for Non-invasive Ventilation in Acute Respiratory Failure
• Actual Study Start Date: Mar 21, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Outcome Measures

Primary Outcome Measures

1. Success vs failure of non invasive ventilation [within 6 months]

   by ROX index calculation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants admitted to RICU with type I and type II respiratory failure requiring

NIV support with one or more of the following :

1. PaO2/FiO2 less than or equal to 300 mmHg despite supplying oxygen at a flow rate ≥ to 10 l/min for ≥ 15 min

2. Patients requiring ventilatory support due to increased respiratory rate ≥ 25 breaths/min or using accessory muscles of respiration

Exclusion Criteria:

• 1. Absolute indication for intubation like coma, hemodynamic instability, or life-threatening arrhythmia.

1. Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy,or active upper gastrointestinal bleeding.

2. Resusal to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kholoud Zakaria, Kholoud Zakaria, Assiut University
• ClinicalTrials.gov Identifier: NCT05309239
• Other Study ID Numbers: CHESTROX
• First Posted: Apr 4, 2022
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Apr 4, 2022