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

NCT ID: NCT05850195

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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).

Conditions

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Non-invasive Ventilation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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non invasive ventilation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Abd El Razek Kamel

lecturer assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Asmaa Razek

Role: CONTACT

01061855512

Raafat El-Sokkary

Role: CONTACT

01006155517

References

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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.

Reference Type BACKGROUND
PMID: 17019559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30576221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23344830 (View on PubMed)

Other Identifiers

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NIV failure in acute RF

Identifier Type: -

Identifier Source: org_study_id

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