Clinical trial NCT04728412: High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation
Official title: High Flow Oxygen Therapy in Patients With or at Risk of Respiratory Failure Undergoing Felxible Bronchoscopy Under Sedation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Failure
Hypercapnic Acidosis
Keywords: bronchoscopy
sedation
high flow oxygen therapy
Lead sponsor: Cardarelli Hospital
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5.
timeFrame: one year
measure: Percent of variation of pH, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
timeFrame: one year
measure: Percent of variation of PaCO2 variation, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
timeFrame: one year
measure: Rate of interruption of bronchoscopy because of number of desaturation, defined as SpO2< 90 percent for >1 min, >5.
timeFrame: one year
measure: Number of partecipants requiring an escalation of respiratory support.
timeFrame: one year
measure: Rate of new appearance of hemodynamic instability.
timeFrame: one year
Secondary outcomes:
measure: value of Charlson Comobidity Index associated with HFOT failure.
timeFrame: one year
measure: value of Body Mass Index associated with HFOT failure.
timeFrame: one year
measure: value of Borg dyspnea scale associated with HFOT failure.
timeFrame: one year
measure: Number of desaturations, defined as SpO2< 90 percent for >1 min.
timeFrame: one year
measure: Lowest oxygen saturation under HFOT.
timeFrame: one year
measure: Rate of change of HFOT parameters because of desaturation without respiratory acidosis.
timeFrame: one year
measure: Rate of change of HFOT parameters because of desaturation with respiratory acidosis
timeFrame: one year
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Giuseppe Failla, MD
Study officials:
References: