The Validity of the ROX Index in Predicting Intubation in Patients With Covid-19 Pneumonia

NCT05150886 | Completed

• 1 other identifier: 2012-KAEK-15/2434
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: ROX index (SpO2 / FiO2) / respiratory rate, which is the ratio of peripheral oxygen saturation (SpO2) and inspired oxygen fraction (FiO2) divided by respiratory rate, to predict failure of HFNO therapy and intubation in patients with a rapid, easy-to-use, rapidly administered pneumonia. index used not to delay. This is a rating. HFNO reduces the need for endotracheal intubation in patients with acute hypoxic respiratory failure due to pneumonia. It has been suggested that HFNO may reduce the need for invasive mechanical ventilation compared to conventional oxygen therapy. Recently, experience has been reported that HFNO therapy also reduces the need for endotracheal intubation in patients with COVID-19 pneumonia. However, there are studies showing that insisting on HFNO and delaying intubation increase mortality in patients with acute respiratory distress syndrome (ARDS) and acute respiratory failure. In this study; We aimed to investigate the validity of the ROX index in predicting HFNO failure in patients with COVID-19 pneumonia admitted to the intensive care unit.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• intubation

  We aimed to investigate the validity of the ROX index in predicting HFNO failure in patients with COVID-19 pneumonia admitted to the intensive care unit.

  3 month

Study Arms (2)

Patients at low risk of intubation

Patients with a ROX index of 4.88 and above measured at the 12th hour of hospitalization in the intensive care unit.

Diagnostic Test: rox index

Patients at hihg risk of intubation

Patients with a ROX index of less than 4.88, measured at the 12th hour of admission to the intensive care unit.

Diagnostic Test: rox index

Interventions

rox index DIAGNOSTIC_TEST

After HFNC during reassessment, the ROX Index can help suggest which patients will fail HFNC and need to progress to intubation for further ventilatory support.

Patients at hihg risk of intubation; Patients at low risk of intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the intensive care unit.

You may qualify if:

• Adult patients (≥18 years of age) with acute respiratory failure due to COVID-19 pneumonia, PCR positive in the nasopharyngeal swab, and HFNO on admission to the intensive care unit will be included in this study.

You may not qualify if:

• Patients under the age of 18 who received non-invasive or invasive mechanical ventilation therapy before HFNO will not be included in the study. Patients with chronic lung disease will be excluded from the study.

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

MESUT

Keçiören, Ankara, (532) 675 84 90, Turkey (Türkiye)

Location

Study Officials

• MESUT DEMİRKÖSE

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 68 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 9, 2021
• Study Start: February 1, 2022
• Primary Completion: March 15, 2022
• Study Completion: April 8, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: It will be available for 4 months as of February 1, 2022
• Access Criteria: The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Locations

TU (1)