Positive Pressure During Bronchoscopy

NCT02167542 | Completed

• 1 other identifier: BroncoNIVCPAP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure With Hypoxia

Keywords

Severe hypoxemic respiratory failure; Fiberoptic bronchoscopy; Noninvasive possitive pressure ventilation; Continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

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

  Before and 5 min after the exam (FOB)

Secondary Outcomes (4)

• Electrocardiogram

  up to 60 min after FOB

• Heart Rate

  up to 60 min after FOB

• Respiratory Rate

  up to 60 min after FOB

• Peripheal oxygen saturation

  up to 60 min after FOB

Study Arms (2)

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.

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.

Device: CPAP valve (Boussignac)

Interventions

Noninvasive Positive Pressure Ventilation DEVICE

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.

NPPV group

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%.

CPAP valve group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sao Joao: lead

Study Sites (1)

Broncology Unit, Pulmonology Department, University Hospital São João

Porto, Porto District, 4200-319, Portugal

Location

Related Publications (1)

• 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.

  PMID: 11948045 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Miguel R Gonçalves, Ph.D

  Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João

  PRINCIPAL INVESTIGATOR

• Tiago F Pinto, MSc

  Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: June 19, 2014
• Study Start: February 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: February 1, 2014
• Last Updated: June 19, 2014

Record last verified: 2014-06

Locations

PT (1)