High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation

Respiratory Failure Clinical Trial

— BroncHoFlow  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04728412
• Other study ID #: 00000
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Cardarelli Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Hypercapnic Acidosis
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Italy	Giuseppe Failla, MD	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Cardarelli Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5.		one year
Primary	Percent of variation of pH, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.		one year
Primary	Percent of variation of PaCO2 variation, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.		one year
Primary	Rate of interruption of bronchoscopy because of number of desaturation, defined as SpO2< 90 percent for >1 min, >5.		one year
Primary	Number of partecipants requiring an escalation of respiratory support.		one year
Primary	Rate of new appearance of hemodynamic instability.		one year
Secondary	value of Charlson Comobidity Index associated with HFOT failure.		one year
Secondary	value of Body Mass Index associated with HFOT failure.		one year
Secondary	value of Borg dyspnea scale associated with HFOT failure.		one year
Secondary	Number of desaturations, defined as SpO2< 90 percent for >1 min.		one year
Secondary	Lowest oxygen saturation under HFOT.		one year
Secondary	Rate of change of HFOT parameters because of desaturation without respiratory acidosis.		one year
Secondary	Rate of change of HFOT parameters because of desaturation with respiratory acidosis		one year