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Clinical Trials/NCT02564406
NCT02564406
Completed
Not Applicable

Extracorporeal CO2 Removal in Hypercapnic Patients Who Failed Noninvasive Ventilation and Refuse Endotracheal Intubation: a Case Series

University of Roma La Sapienza1 site in 1 country35 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
University of Roma La Sapienza
Enrollment
35
Locations
1
Primary Endpoint
number of patients who avoided endotracheal intubation
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Noninvasive ventilation represents the standard of care for patients with exacerbation of chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe forms of acute hypercapnic respiratory failure and patients must undergo endotracheal intubation and invasive ventilation to restore adequate gas exchange. Under these circumstances, patients may express a clear intention not to be intubated.The aim of this study is to retrospectively assess efficacy and safety of noninvasive ventilation- plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.

Detailed Description

During a period of two years (from January 2013 to July 2015) 35 patients with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease, refused endotracheal intubation after failing NIV and were treated with extracorporeal Co2 removal plus NIV as last resort therapy. The collected data of these patients will be retrospectively matched with data obtained from 35 historical controls who received conventional treatment with endotracheal intubation. The study will retrospectively compare intubation rate, acid base homeostasis, norepinephrine requirements (in the patients who due to clinical conditions were under norepinephrine before starting extracorporeal Co2 removal ) and coagulation parameters.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
September 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Andrea Morelli

MD. Associate professor

University of Roma La Sapienza

Eligibility Criteria

Inclusion Criteria

  • exacerbation of chronic obstructive pulmonary disease
  • failure of non invasive ventilation
  • expression of a clear intention not to be intubated

Exclusion Criteria

  • alterations in mental status which do not allow to express a clear intention not to be intubated
  • contraindications to anticoagulation

Outcomes

Primary Outcomes

number of patients who avoided endotracheal intubation

Time Frame: 60 days

Secondary Outcomes

  • Gas exchange homeostasis(96 hrs)
  • Norepinephrine requirements(30 days)
  • coagulation(30 days)
  • Day 28 mortality(28 days)
  • intra hospital mortality(180 days)

Study Sites (1)

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