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

NCT05850195 | Unknown

• 1 other identifier: NIV failure in acute RF
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Non-invasive Ventilation

Outcome Measures

Primary Outcomes (14)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Interventions

non invasive ventilation OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of both gender with acute respiratory failure either hypoxic or hypercapnic who need Noninvasive ventilation.

You may qualify if:

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

You may not qualify if:

• Age \< 18 years old.
• 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.
• neuromuscular disease or chest wall deformities.
• Pregnancy.
• NIV intolerance.
• severe obesity with Body Mass Index (BMI)≥35 kg/m2

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 17019559 BACKGROUND

• 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.

  PMID: 30576221 BACKGROUND

• 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.

  PMID: 23344830 BACKGROUND

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Asmaa Razek

CONTACT

01061855512; drasmaarazek85@gmail.com

Raafat El-Sokkary

CONTACT

01006155517; elsokkary100@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer assistant

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 9, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-03