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Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure

Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05850195
Enrollment
70
Registered
2023-05-09
Start date
2023-06-01
Completion date
2025-06-01
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-invasive Ventilation

Brief summary

This study will use different indices for prediction of NIV failure in ARF patients Evaluation of HACOR score and ROX index for early prediction of NIV failure in patients with ARF. Study value of diaphragmatic dysfunction assessed by ultrasound as tool for prediction of success of NIV in ARF patients. Compare clinical significance of these scoring systems between hypoxemic and hypercapnic RF

Detailed description

Noninvasive ventilation (NIV) is a useful and safe method to improve gas exchange in patients with acute respiratory failure (ARF) of different etiologies. NIV reduces the work of breathing, improves arterial oxygenation and alveolar ventilation. It is associated with improved survival in the acute care setting (Cabrini L 2015) when compared to conventional oxygen therapy. As NIV offers several major advantages over invasive ventilation (e.g., preserving the ability to swallow, cough, and communicate verbally), it is widely used to avoid intubation. Although NIV nowadays is frequently used, its failure rate remains high (25-59%), indicating that not all patients benefit from this treatment. There is an association between the unsuccessful NIV and the poor outcome has been suggested. Among patients who experience NIV failure, either premature or delayed NIV discontinuation further increases mortality. Thus, identifying the predictors of NIV failure is crucial because of the strong link between failure and poor outcomes. So, researchers woke to make scoring systems that may predict NIV failure, as HACOR and ROX indices. Recently, ultrasonography (US) of the diaphragm as a bedside method is used for evaluation of diaphragmatic function and predicting failure of NIV in acutely ill patients. Up till now there is limited research to support significance of different indices for prediction of NIV failure and need for invasive mechanical ventilation (IMV).

Interventions

OTHERnon invasive ventilation

compare indices and diaphragmatic ultrasonography for prediction of NIV failure in acute RF patients

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

1. Patients with acute hypoxic respiratory failure who need Noninvasive ventilation. 2. Patients with acute hypercapnic respiratory failure who need Noninvasive ventilation.

Exclusion criteria

1. Age \< 18 years old. 2. Patients with unconsciousness, severe hemodynamic instability, unable to fit mask (Recent facial surgery, trauma, or deformity), inability to protect the airway or clear respiratory secretions or any other contraindication of NIV. 3. neuromuscular disease or chest wall deformities. 4. Pregnancy. 5. NIV intolerance. 6. severe obesity with Body Mass Index (BMI)≥35 kg/m2

Design outcomes

Primary

MeasureTime frameDescription
measure value of HACOR score for prediction of failure of NIV in ARF patients.Baseline (before starting NIV treatment)HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or \> 5
measure value of ROX index for prediction of failure of NIV in ARF patients.Baseline (before starting NIV treatment)ROX index is the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR). It will be analyzed as continuous value and dichotomized as \< or ≥ 4.88
diaphragmatic thickness assessment by ultrasoundat first 1 day of starting NIV treatmentultrasonographic measurement of diaphragmatic thickness fraction for prediction of failure of NIV in ARF patients.
diaphragmatic dysfunction assessment by ultrasoundat first 1 day of starting NIV treatmentultrasonographic measurement of diaphragmatic excursion for prediction of failure of NIV in ARF patients.

Contacts

Primary ContactAsmaa Razek
drasmaarazek85@gmail.com01061855512
Backup ContactRaafat El-Sokkary
elsokkary100@yahoo.com01006155517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026