High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation

NCT04728412 | Not Yet Recruiting

• 1 other identifier: 00000
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Hypercapnic Acidosis

Keywords

bronchoscopy; sedation; high flow oxygen therapy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (1)

patients undergoing bronchoscopy under sedation with or at risk of respiratory failure

EXPERIMENTAL

Device: High Flow Oxygen Therapy (HFOT)

Interventions

High Flow Oxygen Therapy (HFOT) DEVICE

HFOT administration in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.

patients undergoing bronchoscopy under sedation with or at risk of respiratory failure

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardarelli Hospital: lead

Study Sites (1)

Giuseppe Failla, MD

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Acidosis, Respiratory

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Interventional Pulmonology Unit

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: January 28, 2021
• Study Start: September 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

IT (1)