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Positive Pressure During Bronchoscopy

NCT02167542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-06-19

No results posted yet for this study

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

Interventions

DEVICE

Noninvasive Positive Pressure Ventilation

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.

DEVICE

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%.

Sponsors & Collaborators

  • Hospital Sao Joao

    lead OTHER

Principal Investigators

  • Miguel R Gonçalves, Ph.D · Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João

  • Tiago F Pinto, MSc · Lung Function and Ventilation Unit, Pulmonology Department, University Hospital São João

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-09-30
Completion
2014-02-28

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02167542 on ClinicalTrials.gov