Acute Respiratory Failure With HypoxiaNCT02167542
Positive Pressure During Bronchoscopy
A study testing Noninvasive Positive Pressure Ventilation and CPAP valve (Boussignac) in people with Acute Respiratory Failure With Hypoxia, run by Hospital Sao Joao at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure With Hypoxia
- What is being tested?
- Noninvasive Positive Pressure Ventilation and CPAP valve (Boussignac)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePortugal
- Study dates
- Feb 2010to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- emergent intubation;
- recent (less than 1 wk) acute myocardial infarction;
- ph bellow 7.30;
- PaCo2 > 60mmHg;
- systolic blood pressure < 80mmHg;
- encephalopathy or coma.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Broncology Unit, Pulmonology Department, University Hospital São João
Porto, Porto District, 4200-319
About this study
Official title: Positive Pressure During Bronchoscopy: Noninvasive Positive Pressure Ventilation vs Continuous Positive Airway Pressure Valve
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.
Read the 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.
- Conditions
- Acute Respiratory Failure With Hypoxia
- Being tested
- Noninvasive Positive Pressure Ventilation, CPAP valve (Boussignac)
- Keywords
- Severe hypoxemic respiratory failure, Fiberoptic bronchoscopy, Noninvasive possitive pressure ventilation, Continuous positive airway pressure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Positive Pressure VentilationDevice
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.
CPAP valve (Boussignac)Device
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%.
| Study group | Role | What they receive |
|---|---|---|
| NPPV group | Experimental | 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. Receives: Device: Noninvasive Positive Pressure Ventilation |
| CPAP valve group | Active comparator | 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. Receives: Device: CPAP valve (Boussignac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial parcial oxygen pressure / Inspired oxygen fraction ratio (PaO2/FiO2)
Measured: Before and 5 min after the exam (FOB)
Secondary outcomes (4)
Electrocardiogram
Measured: up to 60 min after FOB
Heart Rate
Measured: up to 60 min after FOB
Respiratory Rate
Measured: up to 60 min after FOB
Peripheal oxygen saturation
Measured: up to 60 min after FOB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startFeb 2010
- Primary completionSep 2010
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Joao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel R. Goncalves, Hospital Sao Joao
- Investigators
- Miguel R Gonçalves, Ph.D, Principal investigator, Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São JoãoTiago F Pinto, MSc, Principal investigator, Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167542
- Sponsor's protocol ID
- BroncoNIVCPAP
- Status last verified
- Jun 2014
- First submitted
- 15 Sep 2011
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11948045
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Pressure During Bronchoscopy: Noninvasive Positive Pressure Ventilation vs Continuous Positive Airway Pressure Valve
- ClinicalTrials.gov ID
- NCT02167542
- Acronym / sponsor ID
- BroncoNIVCPAP
- Conditions
- Acute Respiratory Failure With Hypoxia
- Keywords
- Severe hypoxemic respiratory failure, Fiberoptic bronchoscopy, Noninvasive possitive pressure ventilation, Continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Sao JoaoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPPV group | Experimental | Device: Noninvasive Positive Pressure VentilationPatients 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. |
| CPAP valve group | Active comparator | Device: CPAP valve (Boussignac)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- emergent intubation;
- recent (less than 1 wk) acute myocardial infarction;
- ph bellow 7.30;
- PaCo2 > 60mmHg;
- systolic blood pressure < 80mmHg;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive Positive Pressure VentilationPatients 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. | Device | NPPV group |
| CPAP valve (Boussignac)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%. | Device | CPAP valve group |
Primary outcome
Change in arterial parcial oxygen pressure / Inspired oxygen fraction ratio (PaO2/FiO2)
Time frame: Before and 5 min after the exam (FOB)
4 secondary outcomes
Electrocardiogram
Time frame: up to 60 min after FOB
Heart Rate
Time frame: up to 60 min after FOB
Respiratory Rate
Time frame: up to 60 min after FOB
Peripheal oxygen saturation
Time frame: up to 60 min after FOB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
- Background: PubMed 11948045Antonelli 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel R Gonçalves, Ph.D principal investigator
Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João
Tiago F Pinto, MSc principal investigator
Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive Positive Pressure Ventilation and CPAP valve (Boussignac) in people with Acute Respiratory Failure With Hypoxia, run by Hospital Sao Joao at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arterial parcial oxygen pressure / Inspired oxygen fraction ratio (PaO2/FiO2) (time frame: Before and 5 min after the exam (FOB)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02167542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.