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

Non-invasive Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05850195
• Other study ID #: NIV failure in acute RF
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Asmaa Razek
• Phone: 01061855512
• Email: drasmaarazek85[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• 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

Related Conditions & MeSH terms

• Non-invasive Ventilation
• Respiratory Insufficiency

Intervention

Other:
• non invasive ventilation
compare indices and diaphragmatic ultrasonography for prediction of NIV failure in acute RF patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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

Outcome

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