Clinical trial NCT04109560: HFNC and Acute Hypercapnic Respiratory Failure
Official title: High Flow Nasal Oxygen Therapy in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure (AHRF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Flow Oxygen Therapy
Acute Hypercapnic Respiratory Failure
COPD Exacerbation
Lead sponsor: Argentinian Intensive Care Society
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moderate to very severe COPD patients (GOLD 2 to 4) admitted to the ICU with acute hypercapnic respiratory failure

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.


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.

Primary outcomes:
measure: Need for non-invasive ventilation
timeFrame: 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.
measure: Need for endotracheal intubation
timeFrame: 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.
Secondary outcomes:
measure: Gas Exchange
timeFrame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
measure: Gas Exchange
timeFrame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
measure: Gas Exchange
timeFrame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
measure: Respiratory variables
timeFrame: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
measure: Respiratory variables
timeFrame: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
measure: Respiratory variables
timeFrame: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
measure: Patient's discomfort
timeFrame: Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Sanatorio Anchorena
Study officials:
affiliation: Sanatorio Anchorena Recoleta
name: Gustavo A Plotnikow
role: STUDY_DIRECTOR
affiliation: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)
name: Mariano Setten
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Médico Policial Churruca-Visca
name: Norberto Tiribelli
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanatorio de la Trinidad Mitre
name: Sebastian Fredes
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanatorio Anchorena San Martín
name: Matias Accoce
role: PRINCIPAL_INVESTIGATOR
References: