High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure

April 14, 2022 updated by: Belfast Health and Social Care Trust

High Flow Nasal Cannula Therapy for Initial Oxygen Administration in Acute Hypercapnic Respiratory Failure - A Comparison Study of Two Current Standards of Care

Chronic lung conditions such as smoking related lung damage lead to breathing fail. This results in accumulation of gases such as carbon-di-oxide in the body especially during periods of illness known as exacerbation.

Current management of carbon-di-oxide accumulation is administration of oxygen, nebulisers, antibiotics etc and if necessary, provide a tight fitting mask around the face to provide breathing support. If this fails, then a patient is placed on a mechanical ventilator. The tight fitting mask therapy is also called non-invasive ventilation and is used widely but patients acceptability of the therapy is limited.

Providing a high flow of air with some oxygen could potentially provide the same benefit of the non-invasive ventilation and may also be better accepted by patients.

Currently the knowledge and evidence from studies suggest a beneficial role for this high flow therapy but this has not been investigated in well designed studies.

In the proposed study we aim to investigate whether use of the high flow therapy reduces the need for non-invasive ventilation in patients who present with a recent onset accumulation of carbon-di-oxide in their body due to long-term lung disease. If this shows benefit, it will lead to a bigger trial with patient benefiting by reduction in the non-invasive ventilation or indeed a need for an invasive breathing machine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Belfast, United Kingdom
        • Recruiting
        • Royal Victoria Hospital
      • Belfast, United Kingdom
        • Recruiting
        • Mater Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patients > 18 years of age
  2. Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 6 KPa

Exclusion Criteria:

  1. Age < 18 years
  2. Pregnant or Breast-Feeding
  3. Patient cannot read and understand English
  4. Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
  5. Hypercapnia secondary to exacerbation of asthma
  6. Contraindication to NIV
  7. Contraindication to HFNC
  8. Not for escalation to NIV
  9. pH < 7.15
  10. GCS 8 or less
  11. Shock defined as systolic < 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation
  12. Respiratory or cardio-respiratory arrest
  13. Any other indication that requires immediate invasive/non-invasive mechanical ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: High flow nasal therapy (HFNT)
Characterized by an elevated arterial CO2 (PaCO2) level of > 6kPa due to ventilatory failure. The ventilatory failure relates to the imbalance between the respiratory demand and the capacity of the respiratory system to match the demand.
Device: High flow nasal therapy
Controlled oxygen administration using at least 20 L/min of flow rate and titrated up as tolerated. Titration of supplemental oxygen to an arterial saturation between 88 - 92%.
Other Names:
  • High flow nasal insufflation
ACTIVE_COMPARATOR: Low flow oxygen (LFO)
Characterized by an elevated arterial CO2 (PaCO2) level of > 6kPa due to ventilatory failure. The ventilatory failure relates to the imbalance between the respiratory demand and the capacity of the respiratory system to match the demand.
Device: Low flow oxygen
Controlled oxygen administration using (venturi mask or nasal cannulae) titrated to an arterial saturation between 88 - 92% as the initial oxygen administration method with a flow rate of <20 L/min.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients requiring NIV in each cohort
Time Frame: 6 hours
Proportion of patients who require NIV by 6 hours of intervention.
6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PaCO2 in Kilopascal
Time Frame: 1 hour, 6 hours and 24 hours.
Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint.
1 hour, 6 hours and 24 hours.
PaO2 in Kilopascal
Time Frame: 1 hour, 6 hours and 24 hours.
Blood arterial PaO2 level measured at the pre-specified time-points or at the nearest time-point.
1 hour, 6 hours and 24 hours.
pH
Time Frame: 1 hour, 6 hours and 24 hours.
pH measured for acid-base status.
1 hour, 6 hours and 24 hours.
Respiratory rate (Breath/minute)
Time Frame: At 1 hour, 6 hours and 24 hours.
Rate of breathing per minute as documented in medical notes.
At 1 hour, 6 hours and 24 hours.
Heart rate (Beat/minute)
Time Frame: 1 hour, 6 hours and 24 hours.
Heart rate per minute as documented in medical notes.
1 hour, 6 hours and 24 hours.
Mean arterial pressure in millimeters of mercury
Time Frame: 1 hour, 6 hours and 24 hours.
Mean arterial pressure in millimeters of mercury as documented in medical notes
1 hour, 6 hours and 24 hours.
Intubation rate
Time Frame: 1 hour, 6 hours and 24 hours.
1 hour, 6 hours and 24 hours.
ICU admission
Time Frame: From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks.
From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks.
In-hospital mortality
Time Frame: From the date of randomization until the date of death or hospital discharge, whichever came first, assessed up to 12 weeks.
From the date of randomization until the date of death or hospital discharge, whichever came first, assessed up to 12 weeks.
ICU length of stay
Time Frame: From the date of ICU admission until the date of last documented ICU discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
From the date of ICU admission until the date of last documented ICU discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
Hospital length of stay
Time Frame: From the date of randomization until hospital discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
From the date of randomization until hospital discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
Dyspnoea
Time Frame: 1 hour, 6 hours and 24 hours.
Dyspnoea will be assessed assessment using a visual analogue scale (VAS), score range 0-10, higher values represent a better outcome)) if patient has capacity or the Likert scale (score range 1-5; higher values represent a better outcome) to be completed by the clinical team (doctor/nurse/physio) if the patient lacks capacity.
1 hour, 6 hours and 24 hours.
Patient comfort
Time Frame: 1 hour.
Comfort will be assessed assessment using a visual analogue scale (VAS), score range 0-10, higher values represent a better outcome)) if patient has capacity or the Likert scale (score range 1-5; higher values represent a better outcome) to be completed by the clinical team (doctor/nurse/physio) if the patient lacks capacity.
1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Belfast Health and Social Care Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19106MA-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD may be shared on request to the Principal Investigator and will be decided on a case by case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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