HFNC and Acute Hypercapnic Respiratory Failure

NCT04109560 | Completed

• 1 other identifier: Hi-VNI in AHRF
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Gas Exchange

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

• Gas Exchange

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

• Gas Exchange

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

• Respiratory variables

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

• Respiratory variables

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Argentinian Intensive Care Society: lead

Study Sites (1)

Sanatorio Anchorena

CABA, 1425, Argentina

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Gustavo A Plotnikow

  Sanatorio Anchorena Recoleta

  STUDY DIRECTOR

• Mariano Setten

  Centro de Educación Médica e Investigaciones Clínicas "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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: August 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

AR (1)