HFNC and Acute Hypercapnic Respiratory Failure

Completed

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

• Registration Number: NCT04109560
• Lead Sponsor: Argentinian Intensive Care Society

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-27
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Study First Posted: 2019-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Need for endotracheal intubation	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	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 Outcome Measures

Name	Time	Method
Gas Exchange	Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment	PaO2 in milimeters of mercury (mmHg) will be recorded
Patient's discomfort	Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment	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).
Respiratory variables	Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment	Thoraco-abdominal asynchrony by "YES or NO" will be recorded

Trial Locations

Locations (1)

Sanatorio Anchorena; 🇦🇷 Caba, Argentina