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Completed

NCT Number: NCT04109560

HFNC and Acute Hypercapnic Respiratory Failure

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.

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Key information

Conditions

High Flow Oxygen Therapy Acute Hypercapnic Respiratory Failure COPD Exacerbation Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanatorio Anchorena

CABA, 1425, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Need for non-invasive ventilation

    Time frame: 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.

  2. Need for endotracheal intubation

    Time frame: 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 outcomes

  1. Gas Exchange

    Time frame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment

    pH will be recorded

  2. Gas Exchange

    Time frame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment

    PaCO2 in milimeters of mercury (mmHg) will be recorded

  3. Gas Exchange

    Time frame: Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment

    PaO2 in milimeters of mercury (mmHg) will be recorded

  4. Respiratory variables

    Time frame: 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

  5. Respiratory variables

    Time frame: Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment

    Accessory muscular use (intercostal or supraclavicular) by "YES or NO" will be recorded

  6. Respiratory variables

    Time frame: 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

  7. Patient's discomfort

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Argentinian Intensive Care Society

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2019
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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