High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation (BroncHoFlow)

High Flow Oxygen Therapy in Patients With or at Risk of Respiratory Failure Undergoing Felxible Bronchoscopy Under Sedation: a Pilot Study

A reduction of peripheral oxygen saturation (SpO2) commonly occurs during bronchoscopy and may be associated with both respiratory and cardiac adverse events. The type of breathing assistance that should be delivered to patients, in order to treat and/or to prevent acute respiratory failure, during or after bronchoscopy, is not universally standardized; studies comparing the impact of different respiratory supports on patient's outcome and on hospital resource use are very few. the risk of respiratory failure rises according to the type of procedure (i.e., increased risk with broncho-alveolar lavage and trans-bronchial lung biopsy) and to the use of sedative drugs. Conventional oxygen therapy with nasal cannula, continuous positive airway pressure and non-invasive ventilation are commonly applied during endoscopic procedures. High flow oxygen therapy (HFOT) is a relatively novel device, still under-used in the context of interventional pulmonology, providing an humidified air-oxygen blend up to 60 L/min. HFOT has been reported to be effective for the treatment of both hypoxemic and hypercapnic respiratory failure. The investigators hypothesize that HFOT could be feasible and safe in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Hypercapnic Acidosis
• Intervention / Treatment: Device: High Flow Oxygen Therapy (HFOT)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Giuseppe Failla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pH ≥7.30 e PaCO2 >45 mmHg and/or
• PaO2/FiO2 <300 mmHg o SpO2 <90 percent on room air
• Patient at risk of respiratory failure (COPD III-IV GOLD stage; OSAS; restrictive lung and chest wall diseases; cardiac failure)

Exclusion Criteria:

• Need of laryngeal mask and/or
• Patients on NIV for >16 hrs/day and/or
• pH <7.30 and/or
• Tracheostomy and/or
• Recent (<3 months) facial trauma and/or
• Hemodynamic instability and/or
• High risk of aspiration and/or
• Lacerated trachea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients undergoing bronchoscopy under sedation with or at risk of respiratory failure	Device: High Flow Oxygen Therapy (HFOT); HFOT administration in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5.	one year
Percent of variation of pH, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.	one year
Percent of variation of PaCO2 variation, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.	one year
Rate of interruption of bronchoscopy because of number of desaturation, defined as SpO2< 90 percent for >1 min, >5.	one year
Number of partecipants requiring an escalation of respiratory support.	one year
Rate of new appearance of hemodynamic instability.	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
value of Charlson Comobidity Index associated with HFOT failure.	one year
value of Body Mass Index associated with HFOT failure.	one year
value of Borg dyspnea scale associated with HFOT failure.	one year
Number of desaturations, defined as SpO2< 90 percent for >1 min.	one year
Lowest oxygen saturation under HFOT.	one year
Rate of change of HFOT parameters because of desaturation without respiratory acidosis.	one year
Rate of change of HFOT parameters because of desaturation with respiratory acidosis	one year

Collaborators and Investigators

• Sponsor: Cardarelli Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: bronchoscopy; sedation; high flow oxygen therapy
• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Acid-Base Imbalance; Respiratory Insufficiency; Acidosis; Acidosis, Respiratory
• Other Study ID Numbers: 00000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No