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Nasal high flow therapy in acute respiratory failure in Chronic Obstructive Pulmonary Disease – A feasibility study.

A feasibility study of Nasal High flow therapy in Acute Hypercapnic Respiratory Failure with Acidosis in patients presenting with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000301369
Acronym
Nil
Enrollment
3
Registered
2017-02-27
Start date
2017-03-13
Completion date
2017-07-17
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This feasibility study aims to determine whether the planned full randomised controlled trial is feasible with the current design, timescale and number of sites. The feasibility study will not directly use the NHF device but instead test parts of the full study design. It comprises 2 parts: Part 1: A usual care protocol for use of NIV in AECOPD with AHRF will be agreed upon between Wellington, Waikato and Christchurch Hospitals. Part 2: Participants will be able to be enrolled in a deferred consent model according to the eligibility criteria in the full RCT and the protocol devised in Part 1 is able to be adhered to in 90%, but at least 75% of cases. Patients presenting with an Acute Exacerbation of COPD will have an Arterial blood gas (ABG) and Venous blood gas (VBG) done as well as usual investigations. If Acute Hypercapnic Respiratory failure (AHRF) with acidosis, defined as PaCO2 greater than 45mmHg and pH of 7.25 - 7.34, is confirmed on ABG, standard medical treatment including Oxygen therapy titrated to oxygen saturations of 88-92% over 60 minutes will be implemented. We will use monitoring equipment with a downloadable function to assess compliance with the agreed standard of care. .A repeat ABG and VBG will be done after 60 minutes. Deferred consent for the use of information will be obtained from patients within 24-48 hours of admission. We intend to run a pilot of 15 patients at Wellington Hospital only while we wait to hear about funding for the full 40 patient feasibility study. This will follow the same protocol as the feasibility study. If funding is secured the target sample size will be increased to 40.

Interventions

A standard of care protocol for Acute Exacerbation of COPD patients with Acute Hypercapnic Respiratory failure (AHRF) with acidosis will be agreed upon with Emergency Department staff. Patients presenting with an Acute Exacerbation of COPD will have an Arterial blood gas (ABG) as per current guidelines and venous blood gas (VBG) as per standard hospital practice. Patients with a PaCO2 greater than 45mmHg and pH of greater than or equal to 7.25 and less than 7.35 will be enrolled into the ob

A standard of care protocol for Acute Exacerbation of COPD patients with Acute Hypercapnic Respiratory failure (AHRF) with acidosis will be agreed upon with Emergency Department staff. Patients presenting with an Acute Exacerbation of COPD will have an Arterial blood gas (ABG) as per current guidelines and venous blood gas (VBG) as per standard hospital practice. Patients with a PaCO2 greater than 45mmHg and pH of greater than or equal to 7.25 and less than 7.35 will be enrolled into the observational study using a deferred consent model. A deferred consent model is required as people with COPD and acute hypercapnic respiratory failure have impaired capacity. All participants will receive standard medical therapy, including oxygen therapy titrated to oxygen saturations of 88-92%, bronchodilators and steroids as appropriate. After the 60 minute optimisation period participants will have a paired ABG and VBG and need for non-invasive ventilation will be assessed. Subsequent care will be determined by the treating physician. During the 60 minute observational period the treatments received will be recorded to allow comparison of treatment received with the agreed standard care protocol. All participants will have their oxygen saturations and heart rate recorded by a pulse oximeter. This data will be downloaded after the 60 minute period completes. As an observational study there is no intervention and all participants will receive standard medical care throughout. Participants will undergo one additional venous blood test that they would not normally require. Deferred consent for the use of data will be obtained from patients once they are well enough to give informed consent. This will usually be within 48 hours of admission. If participants do not give consent their data will not be used in the study analysis.

Sponsors

Medical Research Institute of New Zealand
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
41 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(1) Diagnosed with AECOPD causing AHRF with acidosis (pH of 7.25 - 7.34 on baseline Arterial Blood Gas) (2) Age > 40 years of age

Exclusion criteria

(1) Patient requiring immediate NIV or intubation; (2) Patients in whom NIV would never be considered clinically appropriate, e.g. advance care plan refusing NIV; (3) Agitation sufficient to preclude study procedures; (4) Specific contra-indications to NIV, e.g: Life-threatening hypoxaemia; Inability to protect airway; facial burns/trauma/recent facial or upper airway surgery; significant nasal/septal pathology; vomiting; fixed upper airway obstruction; undrained pneumothorax; copious respiratory secretions; haemodynamic instability requiring inotropes/vasopressors; pregnancy or breastfeeding.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026