None listed
Conditions
Brief summary
This study is investigating a new way of giving oxygen to people who are unwell in hospital. The study will compare giving oxygen which is automatically adjusted by a device to oxygen which is manually adjusted by doctors and nurses. Both types of oxygen are given through the nose at high flow. The study is designed to find out if automatic oxygen adjustment is able to keep blood oxygen levels in a good target range more effectively than oxygen with manual adjustment.
Interventions
Participants randomized to the intervention will receive nasal high-flow (NHF) therapy using the NHFO2 device with automatic oxygen titration for a period of 24 hours.
Study investigators will be qualified medical doctors with a minimum of 2 years clinical experience. At the start of the study period an investigator will take a capillary blood gas. A study investigator will set up the NHFO2 device using new consumables included heating breathing tube and nasal cannula. A pulse oximeter sensor w
Participants randomized to the intervention will receive nasal high-flow (NHF) therapy using the NHFO2 device with automatic oxygen titration for a period of 24 hours. Study investigators will be qualified medical doctors with a minimum of 2 years clinical experience. At the start of the study period an investigator will take a capillary blood gas. A study investigator will set up the NHFO2 device using new consumables included heating breathing tube and nasal cannula. A pulse oximeter sensor will be attached to the participant's finger which will provide feedback to the NHFO2 device. A second independent sensor and pulse oximeter will be attached to a different finger. The device will entrain oxygen from a wall oxygen outlet. The NHFO2 device will be set to automatic oxygen titration mode with a target peripheral oxygen saturation (SpO2) between 92 and 96% or 88 and 92% as per the target set by the treating clinical team. A study investigator will set the initial inspired oxygen concentration (FiO2) to maintain SpO2 within target range. Flow will be set to 35L/min or to the same flow as used on the pre-study NHF device if the participant was already using NHF. Temperature will be set to 37°C. This can be adjusted to a minimum of 31°C, at request of the participant. FiO2 will be automatically adjusted between pre-set limits. An investigator will remain with the participant for the first 30 minutes after device set-up to ensure NHF is tolerated by the participant. Capital and Coast District Health Board (CCDHB) nursing and medical staff will be trained by a study investigator how to use the NHFO2 device with automatic oxygen titration. Staff will be instructed how to change FiO2 limits, temperature, flow and how to respond to device alarms. High and low SpO2 alarms will be set on the NHFO2 device and the independent pulse oximeter. Nursing staff will be instructed to record SpO2, at a frequency determined by early warning score and hospital protocol, as per routine practice. Participants will receive medical review according to the hospital’s early warning score system as per standard practice. Participants will be withdrawn from the study in the event of a requirement for >50% FiO2 (92-96% group) or >40% FiO2 (88-92% group) or if an absolute increase from baseline of >10% FiO2 is required (both groups) at rest for > 10 minutes. At the end of the 24 hour study period, a second capillary blood gas will be obtained by a study investigator. At this point participant’s involvement in the study will end and they will resume conventional oxygen therapy which will be applied and titrated by a doctor or nurse looking after the patient. All other aspects of medical care will continue as usual during the study period.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: Target SpO2 88-82% 1) Current inpatient under the care of a medical or surgical team 2) Expected duration of admission >24 hours from enrolment 3) Target SpO2 of 88-92% documented by clinical team 4) NHF therapy already commenced OR treating physician decision to start NHF OR requirement for greater than or equal to 1L/min low-flow oxygen Inclusion Criteria: Target SpO2 92-96% 1) Current inpatient under the care of a medical or surgical team 2) Expected duration of admission >24 hours from enrolment 3) Target SpO2 of 92-96% documented by clinical team 4) NHF therapy already commenced OR treating physician decision to start NHF OR requirement for greater than or equal to 2L/min low-flow oxygen
Exclusion criteria
Common Exlusion Criteria: 1) Age < 18 2) Unable to tolerate a brief interruption in oxygen therapy 3) Domiciliary use of CPAP or NIV 4) Diagnosis of obstructive sleep apnoea 5) Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria 6) Haemodynamic instability (systolic blood pressure <90mmHg or requirement for vasopressor or inotropic support) 7) Patient receiving end of life care 8) Risk of barotrauma (as assessed by the investigator) 9) Nasal or facial conditions precluding use of NHF 10) Intracranial trauma or trans-nasal neurosurgery (within 6 weeks) 11) Any condition which limits the feasibility of continuous SpO2 monitoring using a finger probe such as anatomical deformity or vascular compromise. 12) Pregnancy or breastfeeding 13) Cognitive impairment or impaired consciousness precluding informed consent 14) Implanted electronic medical device (including insulin pump, pacemaker, neurostimulator and implantable cardioverter-defibrilator) 14) Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results Exclusion Criteria: Target SpO2 88-92% 1) Requirement for > 35% oxygen at time of enrolment (equivalent to 4L/min low-flow oxygen) 2) Respiratory acidosis (pH <7.35 and pCO2 >45mmHg) Patients with a target SpO2 range of 88-92% and compensated hypercapnia will be eligible for inclusion, however those with a respiratory acidosis will be excluded from the study. Exclusion Criteria: Target SpO2 92-96% 1) Requirement for > 40% oxygen at time of enrolment (equivalent to 5L/min low-flow oxygen) 2) Hypercapnia (pCO2 >45mmHg) with or without acidosis 3) Presence of any risk factor for hypercapnic respiratory failure including: COPD, cystic fibrosis, bronchiectasis, chest wall deformity or neuromuscular disease AND investigator considers 92-96% to be an inappropriate SpO2 target.
Outcome results
None listed