HFNC and Acute Hypercapnic Respiratory Failure

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

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.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation; Acute Hypercapnic Respiratory Failure; High Flow Oxygen Therapy

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, 1425
    • Sanatorio Anchorena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for non-invasive ventilation	The need and causes for non-invasive ventilation will be recorded in the all study period.	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.
Need for endotracheal intubation	The need and causes for endotracheal intubation will be recorded in the all study period.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gas Exchange	pH will be recorded	Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Gas Exchange	PaCO2 in milimeters of mercury (mmHg) will be recorded	Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Gas Exchange	PaO2 in milimeters of mercury (mmHg) will be recorded	Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Respiratory variables	Respiratory rate in numbers of breaths per minute (bpm) will be recorded	Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Respiratory variables	Accessory muscular use (intercostal or supraclavicular) by "YES or NO" will be recorded	Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Respiratory variables	Thoraco-abdominal asynchrony by "YES or NO" will be recorded	Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment
Patient's discomfort	Discomfort related to the high flow oxygen therapy and related to the degree of humidification will be assessed by using a numerical rating scale from 1 (no discomfort) to 5 (maximum imaginable discomfort). Patients will be asked to rate their discomfort with the used device and discomfort symptoms will be determined for the dryness of the delivered oxygen (dryness of the mouth, throat, nose, difficulty to swallow and throat pain).	Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment

Collaborators and Investigators

• Sponsor: Argentinian Intensive Care Society
• Investigators: Study Director: Gustavo A Plotnikow, Sanatorio Anchorena Recoleta; Principal Investigator: Mariano Setten, Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC); Principal Investigator: Norberto Tiribelli, Complejo Médico Policial Churruca-Visca; Principal Investigator: Sebastian Fredes, Sanatorio de la Trinidad Mitre; Principal Investigator: Matias Accoce, Sanatorio Anchorena San Martín

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: Hi-VNI in AHRF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No