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

Primary Purpose

Respiratory Failure, Hypercapnic Acidosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High Flow Oxygen Therapy (HFOT)
Sponsored by
Cardarelli Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring bronchoscopy, sedation, high flow oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Giuseppe Failla, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

value of Charlson Comobidity Index associated with HFOT failure.
value of Body Mass Index associated with HFOT failure.
value of Borg dyspnea scale associated with HFOT failure.
Number of desaturations, defined as SpO2< 90 percent for >1 min.
Lowest oxygen saturation under HFOT.
Rate of change of HFOT parameters because of desaturation without respiratory acidosis.
Rate of change of HFOT parameters because of desaturation with respiratory acidosis

Full Information

First Posted
December 12, 2020
Last Updated
February 8, 2023
Sponsor
Cardarelli Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04728412
Brief Title
High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation
Acronym
BroncHoFlow
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardarelli Hospital

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Hypercapnic Acidosis
Keywords
bronchoscopy, sedation, high flow oxygen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients undergoing bronchoscopy under sedation with or at risk of respiratory failure
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
High Flow Oxygen Therapy (HFOT)
Intervention Description
HFOT administration in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.
Primary Outcome Measure Information:
Title
Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5.
Time Frame
one year
Title
Percent of variation of pH, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
Time Frame
one year
Title
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
Title
Rate of interruption of bronchoscopy because of number of desaturation, defined as SpO2< 90 percent for >1 min, >5.
Time Frame
one year
Title
Number of partecipants requiring an escalation of respiratory support.
Time Frame
one year
Title
Rate of new appearance of hemodynamic instability.
Time Frame
one year
Secondary Outcome Measure Information:
Title
value of Charlson Comobidity Index associated with HFOT failure.
Time Frame
one year
Title
value of Body Mass Index associated with HFOT failure.
Time Frame
one year
Title
value of Borg dyspnea scale associated with HFOT failure.
Time Frame
one year
Title
Number of desaturations, defined as SpO2< 90 percent for >1 min.
Time Frame
one year
Title
Lowest oxygen saturation under HFOT.
Time Frame
one year
Title
Rate of change of HFOT parameters because of desaturation without respiratory acidosis.
Time Frame
one year
Title
Rate of change of HFOT parameters because of desaturation with respiratory acidosis
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Giuseppe Failla, MD
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

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High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation

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