HFNC and Acute Hypercapnic Respiratory Failure

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04109560

Enrollment

Registered

2019-09-30

Start date

2018-08-01

Completion date

2019-09-30

Last updated

2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypercapnic Respiratory Failure, COPD Exacerbation, High Flow Oxygen Therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
Gas Exchange	Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment	pH will be recorded
Respiratory variables	Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment	Respiratory rate in numbers of breaths per minute (bpm) 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).

Countries

Argentina

Outcome results