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Positive Pressure During Bronchoscopy

Primary Purpose

Acute Respiratory Failure With Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Noninvasive Positive Pressure Ventilation
CPAP valve (Boussignac)
Sponsored by
Hospital Sao Joao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure With Hypoxia focused on measuring Severe hypoxemic respiratory failure, Fiberoptic bronchoscopy, Noninvasive possitive pressure ventilation, Continuous positive airway pressure

Eligibility Criteria

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

Inclusion Criteria:

  • need for FOB;
  • hypoxemia, defined by pulse oximetry (SpO2) >92% under oxygen supplementation;
  • mild hypercapnia, defined by transcutaneous CO2 (PaCO2) <60mmHg;
  • already under domiciliary NPPV.

Exclusion Criteria:

  • emergent intubation;
  • recent (less than 1 wk) acute myocardial infarction;
  • ph bellow 7.30;
  • PaCo2 > 60mmHg;
  • systolic blood pressure < 80mmHg;
  • encephalopathy or coma.

Sites / Locations

  • Broncology Unit, Pulmonology Department, University Hospital São João

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NPPV group

CPAP valve group

Arm Description

Patients assigned to noninvasive positive pressure ventilation (NPPV) are connected to the ventilator through a face mask (VBM Endoscopy Mask) that is secured to the patient's face by the investigator.

Patients assigned to CPAP valve (Boussignac valve, Vygon, Inc) are connected to this device through a standard face mask that is secured to the patient's face with elastic straps.

Outcomes

Primary Outcome Measures

Change in arterial parcial oxygen pressure / Inspired oxygen fraction ratio (PaO2/FiO2)

Secondary Outcome Measures

Electrocardiogram
Heart Rate
Respiratory Rate
Peripheal oxygen saturation

Full Information

First Posted
September 15, 2011
Last Updated
June 18, 2014
Sponsor
Hospital Sao Joao
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1. Study Identification

Unique Protocol Identification Number
NCT02167542
Brief Title
Positive Pressure During Bronchoscopy
Official Title
Positive Pressure During Bronchoscopy: Noninvasive Positive Pressure Ventilation vs Continuous Positive Airway Pressure Valve
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It has been demonstrated the application of noninvasive positive pressure ventilation (NPPV) to assist spontaneous breathing through a face mask during fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in severely hypoxemic, nonintubated patients. With NPPV, FOB was well-tolerated, significantly improved the PaO2/FiO2 ratio, and successfully avoided the need for endotracheal intubation. Two randomized studies have provided supporting evidence that the application of NPPV or CPAP via a face mask was superior to oxygen supplementation alone during FOB. For this reason patients who require FOB and are hypoxemic and/or mild hypercapnic (TcCO2 < 60mmHg) will be compared in a randomized study by comparing NPPV vs CPAP Boussignac (Vygon) delivered through a face mask.
Detailed Description
Since its introduction in the late 1960s, fiberoptic bronchoscopy (FOB) has been increasingly used for diagnostic and therapeutic purposes. Because arterial oxygen tension (PaO2) usually decreases by 10 to 20 mm Hg after uncomplicated bronchoscopy, severe hypoxemia in nonintubated patients is an accepted contraindication to bronchoscopy. The American Thoracic Society recommends avoiding bronchoalveolar lavage (BAL) in spontaneously breathing patients with hypercapnia or hypoxemia that cannot be corrected to at least a PaO2 of 75 mm Hg or to oxygen saturation greater than 90% with supplemental oxygen (1). In these high-risk patients, the options are to intubate and to apply mechanical ventilation (MV) to ensure adequate gas exchange during FOB or to avoid FOB and to institute empirical treatment. This limitation has prompted the development of techniques of respiratory support to make the FOB procedure safer for hypoxemic or critically ill patients, without using invasive ventilation. It has been demonstrated the application of noninvasive positive pressure ventilation (NPPV) to assist spontaneous breathing through a face mask during FOB with BAL in severely hypoxemic, nonintubated patients (2). FOB was well-tolerated, significantly improved the PaO2/FiO2 ratio, and successfully avoided the need for endotracheal intubation. Two randomized studies have provided supporting evidence that the application of NPPV or CPAP via a face mask was superior to oxygen supplementation alone during FOB (3,4). For this reason patients who require FOB and are hypoxemic and/or mild hypercapnic (TcCO2 < 60mmHg) will be compared in a randomized study by comparing NPPV vs CPAP Boussignac (Vygon) delivered through a face mask. Methods Adult patients will be recuited in Bronchology Department and Intensive Care Units of the Hospital S. João, EPE. Only when inclusion criteria and a written informed consent of participation have been obtained from the patient, they will enter this study. Before undergoing bronchoscopy all patients will be evaluate by SpO2, TCCO2, arterial blood pressure (ABP), heart rate (HR), respiratory rate (RR) and ECG. Patients with SpO2<92%, oxygen supplementation will be provided to achieve SpO2>92%. At this stage all patients will be randomly assigned to receive NPPV or CPAP Boussignac through a face mask during bronchoscopy. During the procedure, patients will be continuous monitored with ECG, ABP, HR, RR, SpO2 and TCCO2. These clinical parameters will be recorded at the following times: 1 - at evaluation; 2 - before the beginning of FOB; 3 - during FOB; 4 - at the end of FOB; 5 - 5, 15, 30, 60 min after FOB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure With Hypoxia
Keywords
Severe hypoxemic respiratory failure, Fiberoptic bronchoscopy, Noninvasive possitive pressure ventilation, Continuous positive airway pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPPV group
Arm Type
Experimental
Arm Description
Patients assigned to noninvasive positive pressure ventilation (NPPV) are connected to the ventilator through a face mask (VBM Endoscopy Mask) that is secured to the patient's face by the investigator.
Arm Title
CPAP valve group
Arm Type
Active Comparator
Arm Description
Patients assigned to CPAP valve (Boussignac valve, Vygon, Inc) are connected to this device through a standard face mask that is secured to the patient's face with elastic straps.
Intervention Type
Device
Intervention Name(s)
Noninvasive Positive Pressure Ventilation
Intervention Description
Patients assigned to NPPV were connected to the ventilator through a face mask (VBM Endoscopy Mask) that was secured to the patient's face by the investigator. Only one type of mechanical ventilator will be used (Vision, Philips Respironics). Ventilator parameters and supplemental oxygen will be titrated by the investigator to achieve SpO2>92%. Ventilatory support via face mask will be maintained with the same pressures for at least 30min after FOB, and then will be replaced by the FIO2 mask's if needed.
Intervention Type
Device
Intervention Name(s)
CPAP valve (Boussignac)
Intervention Description
Patients assigned to CPAP Boussignac valve are connected to this device through a face mask that is secured to the patient's face with elastic straps. This kind of CPAP allows the delivery of pressure by constant-flow oxygen insufflation. Four funnel-shaped microchannels are included in the wall of this device and connected to an external opening connected to the oxygen source. These microchannels generate high-velocity microjets, which in turn generate the pressure resulting from the air entrainment mechanism thus created. Oxygen flow will be titrated by the investigator to ensure SpO2>92%.
Primary Outcome Measure Information:
Title
Change in arterial parcial oxygen pressure / Inspired oxygen fraction ratio (PaO2/FiO2)
Time Frame
Before and 5 min after the exam (FOB)
Secondary Outcome Measure Information:
Title
Electrocardiogram
Time Frame
up to 60 min after FOB
Title
Heart Rate
Time Frame
up to 60 min after FOB
Title
Respiratory Rate
Time Frame
up to 60 min after FOB
Title
Peripheal oxygen saturation
Time Frame
up to 60 min after FOB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: need for FOB; hypoxemia, defined by pulse oximetry (SpO2) >92% under oxygen supplementation; mild hypercapnia, defined by transcutaneous CO2 (PaCO2) <60mmHg; already under domiciliary NPPV. Exclusion Criteria: emergent intubation; recent (less than 1 wk) acute myocardial infarction; ph bellow 7.30; PaCo2 > 60mmHg; systolic blood pressure < 80mmHg; encephalopathy or coma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel R Gonçalves, Ph.D
Organizational Affiliation
Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tiago F Pinto, MSc
Organizational Affiliation
Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João
Official's Role
Principal Investigator
Facility Information:
Facility Name
Broncology Unit, Pulmonology Department, University Hospital São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
11948045
Citation
Antonelli M, Conti G, Rocco M, Arcangeli A, Cavaliere F, Proietti R, Meduri GU. Noninvasive positive-pressure ventilation vs. conventional oxygen supplementation in hypoxemic patients undergoing diagnostic bronchoscopy. Chest. 2002 Apr;121(4):1149-54. doi: 10.1378/chest.121.4.1149.
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Positive Pressure During Bronchoscopy

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