Clinical trial NCT05850195: Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure
Official title: Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-invasive Ventilation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both gender with acute respiratory failure either hypoxic or hypercapnic who need Noninvasive 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).

Eligibility criteria: 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

Primary outcomes:
measure: measure value of HACOR score for prediction of failure of NIV in ARF patients.
timeFrame: Baseline (before starting NIV treatment)
measure: measure value of HACOR score for prediction of failure of NIV in ARF patients.
timeFrame: at 1 hour of NIV treatment
measure: measure value of HACOR score for prediction of failure of NIV in ARF patients.
timeFrame: at 6 hours of NIV treatment
measure: measure value of HACOR score for prediction of failure of NIV in ARF patients.
timeFrame: at 12 hours of NIV treatment
measure: measure value of HACOR score for prediction of failure of NIV in ARF patients.
timeFrame: at 24 hours of NIV treatment
measure: measure value of HACOR score for prediction of failure of NIV in ARF patients.
timeFrame: at 48 hours of NIV treatment
measure: measure value of ROX index for prediction of failure of NIV in ARF patients.
timeFrame: Baseline (before starting NIV treatment)
measure: measure value of ROX index for prediction of failure of NIV in ARF patients.
timeFrame: at first hour of NIV treatment
measure: measure value of ROX index for prediction of failure of NIV in ARF patients.
timeFrame: at 6 hours of NIV treatment
measure: measure value of ROX index for prediction of failure of NIV in ARF patients.
timeFrame: at 12 hours of NIV treatment
measure: measure value of ROX index for prediction of failure of NIV in ARF patients.
timeFrame: at 24 hours of NIV treatment
measure: measure value of ROX index for prediction of failure of NIV in ARF patients.
timeFrame: at 48 hours of NIV treatment
measure: diaphragmatic thickness assessment by ultrasound
timeFrame: at first 1 day of starting NIV treatment
measure: diaphragmatic dysfunction assessment by ultrasound
timeFrame: at first 1 day of starting NIV treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.
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.