HFNC and Acute Hypercapnic Respiratory Failure

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109560
• Other study ID #: Hi-VNI in AHRF
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Argentinian Intensive Care Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Hypercapnic Respiratory Failure
• COPD Exacerbation
• High Flow Oxygen Therapy
• Hypercapnia
• Respiratory Insufficiency

Locations

Country	Name	City	State
Argentina	Sanatorio Anchorena	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Argentinian Intensive Care Society

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Gas Exchange	pH will be recorded	Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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