Skip to content

High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04728412
Acronym
BroncHoFlow
Enrollment
100
Registered
2021-01-28
Start date
2024-09-01
Completion date
2025-12-30
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnic Acidosis, Respiratory Failure

Keywords

bronchoscopy, sedation, high flow oxygen therapy

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.

Interventions

DEVICEHigh 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.

Sponsors

Cardarelli Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
value of Charlson Comobidity Index associated with HFOT failure.one year
Rate of change of HFOT parameters because of desaturation with respiratory acidosisone 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026