Non-invasive Ventilation Clinical Trial
Official title:
Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure
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
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | June 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Demoule A, Girou E, Richard JC, Taille S, Brochard L. Benefits and risks of success or failure of noninvasive ventilation. Intensive Care Med. 2006 Nov;32(11):1756-65. doi: 10.1007/s00134-006-0324-1. Epub 2006 Sep 21. — View Citation
Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24. — View Citation
Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | measure value of HACOR score for prediction of failure of NIV in ARF patients. | HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as = or > 5 | Baseline (before starting NIV treatment) | |
Primary | measure value of HACOR score for prediction of failure of NIV in ARF patients. | HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as = or > 5 | at 1 hour of NIV treatment | |
Primary | measure value of HACOR score for prediction of failure of NIV in ARF patients. | HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as = or > 5 | at 6 hours of NIV treatment | |
Primary | measure value of HACOR score for prediction of failure of NIV in ARF patients. | HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as = or > 5 | at 12 hours of NIV treatment | |
Primary | measure value of HACOR score for prediction of failure of NIV in ARF patients. | HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as = or > 5 | at 24 hours of NIV treatment | |
Primary | measure value of HACOR score for prediction of failure of NIV in ARF patients. | HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) It will be analyzed as continuous value and dichotomized as = or > 5 | at 48 hours of NIV treatment | |
Primary | measure value of ROX index for prediction of failure of NIV in ARF patients. | 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 | Baseline (before starting NIV treatment) | |
Primary | measure value of ROX index for prediction of failure of NIV in ARF patients. | 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 | at first hour of NIV treatment | |
Primary | measure value of ROX index for prediction of failure of NIV in ARF patients. | 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 | at 6 hours of NIV treatment | |
Primary | measure value of ROX index for prediction of failure of NIV in ARF patients. | 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 | at 12 hours of NIV treatment | |
Primary | measure value of ROX index for prediction of failure of NIV in ARF patients. | 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 | at 24 hours of NIV treatment | |
Primary | measure value of ROX index for prediction of failure of NIV in ARF patients. | 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 | at 48 hours of NIV treatment | |
Primary | diaphragmatic thickness assessment by ultrasound | ultrasonographic measurement of diaphragmatic thickness fraction for prediction of failure of NIV in ARF patients. | at first 1 day of starting NIV treatment | |
Primary | diaphragmatic dysfunction assessment by ultrasound | ultrasonographic measurement of diaphragmatic excursion for prediction of failure of NIV in ARF patients. | at first 1 day of starting NIV treatment |
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