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Clinical Trials/NCT04109560
NCT04109560
Completed
N/A

High Flow Nasal Oxygen Therapy in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure (AHRF)

Argentinian Intensive Care Society1 site in 1 country40 target enrollmentAugust 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
High Flow Oxygen Therapy
Sponsor
Argentinian Intensive Care Society
Enrollment
40
Locations
1
Primary Endpoint
Need for endotracheal intubation
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

High-flow nasal cannula (HFNC) enables delivering humidified gas at high-flow rates controlling the oxygen inspired fraction (FiO2). Its efficacy has been demonstrated in hypoxemic acute respiratory failure. However, little is known about its use in hypercapnic acute respiratory failure (ARF). Therefore, we aimed to evaluate the effect of using HFNC through "Precision Flow" equipment as first line of ventilatory support for COPD patients with hypercapnic acute respiratory failure.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Argentinian Intensive Care Society
Responsible Party
Principal Investigator
Principal Investigator

Gustavo Plotnikow

Physical Therapist

Argentinian Intensive Care Society

Eligibility Criteria

Inclusion Criteria

  • Moderate to very severe COPD patients (GOLD 2 to 4) over 18 years old admitted to the ICU with hypercapnic ARF (PaCO2\> 45 mmHg and respiratory acidosis \[pH ≥7.30\], with or without hypoxemia + one of the following: Respiratory Rate ≥25 cycles per minute, intercostal and / or supraclavicular recruitment, or thoraco-abdominal synchrony, no prior use of NIV)

Exclusion Criteria

  • Patients less than 18 years old
  • Mild COPD patients
  • Absence of hypercapnia
  • Kelly M Score \> 3
  • Haemodynamic instability (despite fluid resuscitation)
  • NIV or Invasive Mechanical Ventilation (IMV) (Need to use previously to HFNC)
  • Contraindications to implement high-flow oxygen therapy.

Outcomes

Primary Outcomes

Need for endotracheal intubation

Time Frame: From inclussion study date until the first day of endotracheal intubation documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.

The need and causes for endotracheal intubation will be recorded in the all study period.

Need for non-invasive ventilation

Time Frame: From inclussion study date until the first day of noninvasive ventilation use documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.

The need and causes for non-invasive ventilation will be recorded in the all study period.

Secondary Outcomes

  • Gas Exchange(Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment)
  • Patient's discomfort(Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment)
  • Respiratory variables(Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment)

Study Sites (1)

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