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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05850195
Collaborator
(none)
70
24

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: non invasive ventilation

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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

  2. measure value of HACOR score for prediction of failure of NIV in ARF patients. [at 1 hour of NIV treatment]

    HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5

  3. measure value of HACOR score for prediction of failure of NIV in ARF patients. [at 6 hours of NIV treatment]

    HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5

  4. measure value of HACOR score for prediction of failure of NIV in ARF patients. [at 12 hours of NIV treatment]

    HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5

  5. measure value of HACOR score for prediction of failure of NIV in ARF patients. [at 24 hours of NIV treatment]

    HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5

  6. measure value of HACOR score for prediction of failure of NIV in ARF patients. [at 48 hours of NIV treatment]

    HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as ≤ or > 5

  7. 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

  8. measure value of ROX index for prediction of failure of NIV in ARF patients. [at first hour of 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

  9. measure value of ROX index for prediction of failure of NIV in ARF patients. [at 6 hours of 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

  10. measure value of ROX index for prediction of failure of NIV in ARF patients. [at 12 hours of 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

  11. measure value of ROX index for prediction of failure of NIV in ARF patients. [at 24 hours of 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

  12. measure value of ROX index for prediction of failure of NIV in ARF patients. [at 48 hours of 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

  13. diaphragmatic thickness assessment by ultrasound [at first 1 day of starting NIV treatment]

    ultrasonographic measurement of diaphragmatic thickness fraction for prediction of failure of NIV in ARF patients.

  14. diaphragmatic dysfunction assessment by ultrasound [at first 1 day of starting NIV treatment]

    ultrasonographic measurement of diaphragmatic excursion for prediction of failure of NIV in ARF patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Asmaa Abd El Razek Kamel, lecturer assistant, Assiut University
ClinicalTrials.gov Identifier:
NCT05850195
Other Study ID Numbers:
  • NIV failure in acute RF
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
Mar 1, 2023
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2023