Clinical Trials Logo
  1. Home
  2. Respiratory Failure
  3. NCT01870765
  4. Details
NCT01870765 Clinical Trial

Safety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.

Respiratory Failure Clinical Trial

Official title:
Prospective Randomised Study on the Safety of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01870765
Other study ID # PV-4442
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date February 2014

Study information
Verified date November 2020
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia. Especially patients with acute or chronic pulmonary diseases are at risk of respiratory failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be performed safely using non-invasive ventilation. It seems probable that high-flow oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of respiratory failure during fiberoptic bronchoscopy while improving patient comfort. In this prospective randomised study the safety of high-flow oxygen is compared with non-invasive ventilation in patients with hypoxemic respiratory failure undergoing fiberoptic bronchoscopy.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients treated in an intensive care unit - indication for bronchoscopy and broncho-alveolar lavage - presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) and/or hypercapnic respiratory failure Exclusion Criteria: - patients already on invasive ventilation - indication for intubation - blocked nasopharynx - contraindications for non-invasive ventilation or high-flow oxygen

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• non-invasive ventilation
non-invasive ventilation via face mask
• high-flow oxygen
high-flow oxygen via nasal cannula
Procedure:
• fiberoptic bronchoscopy
fiberoptic bronchoscopy including broncho-alveolar lavage

Locations
Country Name City State
Germany Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Requirement of intubation after the completion of bronchoscopy. 8 hours after the completion of bronchoscopy
Primary Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy. during fiberoptic bronchoscopy
Secondary Changes in blood gases after the completion of fiberoptic bronchoscopy. 1 hour after the completion of bronchoscopy
See also
  Status Clinical Trial Phase
Completed NCT03909854 - Pragmatic Investigation of Volume Targeted Ventilation-1 N/A
Recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT05535543 - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed NCT04030208 - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation N/A
Recruiting NCT04668313 - COVID-19 Advanced Respiratory Physiology (CARP) Study
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04505592 - Tenecteplase in Patients With COVID-19 Phase 2
Completed NCT03943914 - Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients. N/A
Active, not recruiting NCT03472768 - The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Completed NCT02265198 - Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT01659268 - Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins N/A
Completed NCT02814994 - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients N/A
Completed NCT01249794 - Non Invasive Ventilation After Cardiac Surgery N/A
Terminated NCT01333059 - Cycling of Sedative Infusions in Critically Ill Pediatric Patients N/A