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NCT Number: NCT02564406

Extracorporeal CO2 Removal in Hypercapnic Patients

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Anesthesiology and Intensive Care

Rome, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR

Device

Primary outcomes

  1. number of patients who avoided endotracheal intubation

    Time frame: 60 days

Secondary outcomes

  1. Gas exchange homeostasis

    Time frame: 96 hrs

    pH, PaCO2, PaO2, bicarbonate, arterial lactate

  2. Norepinephrine requirements

    Time frame: 30 days

    norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal

  3. coagulation

    Time frame: 30 days

    INR, pt, ptt. platelets

  4. Day 28 mortality

    Time frame: 28 days

  5. intra hospital mortality

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2015
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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