HFNC and Acute Hypercapnic Respiratory Failure

NCT ID: NCT04109560

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High Flow Oxygen Therapy Acute Hypercapnic Respiratory Failure COPD Exacerbation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Argentinian Intensive Care Society

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gustavo Plotnikow

Physical Therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gustavo A Plotnikow

Role: STUDY_DIRECTOR

Sanatorio Anchorena Recoleta

Mariano Setten

Role: PRINCIPAL_INVESTIGATOR

Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)

Norberto Tiribelli

Role: PRINCIPAL_INVESTIGATOR

Complejo Médico Policial Churruca-Visca

Sebastian Fredes

Role: PRINCIPAL_INVESTIGATOR

Sanatorio de la Trinidad Mitre

Matias Accoce

Role: PRINCIPAL_INVESTIGATOR

Sanatorio Anchorena San Martín

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanatorio Anchorena

CABA, , Argentina

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hi-VNI in AHRF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.