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

• ClinicalTrials.gov Identifier: NCT04728412
• Recruitment Status: Active, not recruiting
• First Posted: January 28, 2021
• Last Update Posted: January 28, 2021
• Sponsor: Cardarelli Hospital
• Information provided by (Responsible Party): Giuseppe Failla, Cardarelli Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Failure; Hypercapnic Acidosis	Device: High Flow Oxygen Therapy (HFOT)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High Flow Oxygen Therapy in Patients With or at Risk of Respiratory Failure Undergoing Felxible Bronchoscopy Under Sedation: a Pilot Study
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: October 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Italy

Giuseppe Failla, MD

Naples, Italy, 80131

Sponsors and Collaborators

Cardarelli Hospital

More Information

• Responsible Party: Giuseppe Failla, Chief of Interventional Pulmonology Unit, Cardarelli Hospital
• ClinicalTrials.gov Identifier: NCT04728412
• Other Study ID Numbers: 00000
• First Posted: January 28, 2021
• Last Update Posted: January 28, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giuseppe Failla, Cardarelli Hospital:

bronchoscopy; sedation; high flow oxygen therapy

Additional relevant MeSH terms:

Respiratory Insufficiency; Acidosis, Respiratory; Acidosis; Respiration Disorders; Respiratory Tract Diseases; Acid-Base Imbalance; Metabolic Diseases