NIV-FOB, HFNC-FOB- Comparison of Methods

NCT05655026 | Unknown DMC

• 1 other identifier: 2202
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to asses safety and indications and contraindications for performing bronchofiberocopy (FB) with respiratory support methods, i.e. non-invasive ventilation (NIV) and high flow nasal oxygen therapy (HFNO). Additionally, researchers want to determine how using these methods could avoid the risk of most common complications such as: hypoxemia-related events, decompensation of chronic respiratory failure, worsening of gas exchange, hemodynamic instability.

Conditions

Respiratory Failure; Hypoxemia; Hypoxemic Respiratory Failure

Keywords

respiratory failure; non invasive ventilation; bronchofiberoscopy

Outcome Measures

Primary Outcomes (3)

• Hypoxemia

  measure by pulsoxymetry, blood gas test. Number of Participants with procedure related complications

  2 years

• Comfort

  Use dedicated questionaire to asses patient condition after bronchoskopy

  2 years

• Safety

  Number of Participants with procedure related complications

  2 years

Study Arms (3)

x≤300 HFNO or standard oxygen supplementation

EXPERIMENTAL

bronchoscopy, taking blood gas, taking blood for blood test

Device: NIV, HFNO

100<x≤200 NIV or HFNO

EXPERIMENTAL

bronchoscopy, taking blood gas, taking blood for blood test

Device: NIV, HFNO

x≤100 NIV or intubation

EXPERIMENTAL

bronchoscopy, taking blood gas, taking blood for blood test, intubation

Device: NIV, HFNO

Interventions

NIV, HFNO DEVICE

Arterial blood pressure and saturation will be measured. Arterial blood gases will be collected to qualify patients to one of the three groups. After qualification, patient will be randomly assigned to a given respiratory support method during FB.

100<x≤200 NIV or HFNO; x≤100 NIV or intubation; x≤300 HFNO or standard oxygen supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years, with indications for bronchoscopy,
• Diagnostic procedure: lung cancer, hemoptysis, BAL in interstitial lung diseases.
• Therapeutic procedure: pneumonia in patients with impaired cough reflex, performed to obtain sputum cultures and bronchial tree toilet, hemoptysis or foreign body aspiration in patients not requiring rigid bronchoscopic management.
• Written informed consent to participate in the study,
• PO2/fiO2≤300 in blood gas test performed directly (within 24 h) during the qualification for FB

You may not qualify if:

• No willingness to participate,
• PO2/fiO2\>300 in arterial blood gases, severe unstable coronary artery disease (CCS III/IV), NYHA III/IV,
• Hemodynamic instability defined as continuous amine influx. Myocardial infarction during the last 2 weeks, without PCI treatment. Unstable angina, severe arrhythmias - especially ventricular,
• Chronic primary pulmonary hypertension confirmed by right heart catherisation in WHO III/IV,
• Unsecured by chest tube pneumothorax,
• Platelet count \<20,000 /µl (without platelet transfusion),
• INR \>2 or APTT \>36 s., in case of diagnostic FB \[18\]
• The study will also not include patients who were intubated before randomization.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Aleksandra

Katowice, Poland

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: December 16, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)