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Comparison of a new device for oxygen therapy with continuous positive airway pressure in healthy volunteers

A new interface combining high flow oxygen through nasal cannula and continuous positive airway pressure: comparative assessment of physiological effects in healthy volunteers

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001526369
Enrollment
14
Registered
2017-11-03
Start date
2017-12-12
Completion date
2018-02-13
Last updated
2018-12-10

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

Conditions

None listed

Brief summary

High flow oxygen therapy through nasal cannula (HFNC) is increasingly used in different clinical situation to assist patients with acute respiratory failure. HFNC is characterized by a low dilution of the administered gas with room air, a dead-space wash out of the upper respiratory airways and the application of a positive end-expiratory pressure (PEEP). However, PEEP is strictly limited to the during the expiration phase of the respiratory cycle, while during inspiration pharyngeal pressure drops to zero or even to negative values. This could be a limitation in case of hypoxemic acute respiratory failure (hARF), because recruitment of lung regions with atelectasis is not assured during the whole respiratory cycle. With continuous positive airway pressure (CPAP), the patient’s airway is maintained throughout the respiratory cycle at a selected constant pressure (PEEP), which is higher than the atmospheric pressure. Among the available interfaces, the helmet has been suggested to be effective in improving patient tolerance allowing more prolonged application of continuous CPAP. However, the heated humidification with helmet is problematic, difficult or almost or impossible because of condensation of water inside the interface ("fog" effect). We therefore designed a new interface joining HFNC with CPAP through helmet, to combine the physiological benefit of these two interfaces. We aim to assess airway pressures during the use of this new device with different gas flows and breathing conditions (primary endpoint). We will also assess the effects of different interfaces on the respiratory drive and effort of the subjects.

Interventions

Intervention consists in the simultaneously application of HFNC and CPAP using a new device. We will invite to participate 14 healthy volunteers (7 male and 7 female), from our ICU staff. After obtaining written informed consent, volunteers will be seated in upright position. After anesthetizing the nose with lidocaine, a 10 French suction catheter will be passed via the nose into the oropharynx. We visually confirmed that the manometry catheter tip was just below the uvula. We will also use e

Intervention consists in the simultaneously application of HFNC and CPAP using a new device. We will invite to participate 14 healthy volunteers (7 male and 7 female), from our ICU staff. After obtaining written informed consent, volunteers will be seated in upright position. After anesthetizing the nose with lidocaine, a 10 French suction catheter will be passed via the nose into the oropharynx. We visually confirmed that the manometry catheter tip was just below the uvula. We will also use end-tidal carbon dioxide monitoring to confirm correct placement and catheter patency. The catheter will be connected to a pressure transducer connected to a laptop computer interface. As necessary, the catheter will be adjusted or suctioned to obtain a clear reading. We will test this new interface combing CPAP (PEEP 10 cmH2O and flow at 60 L/min) and HFNC at increasing flow rates (30, 40, 50 and 60 L/min), performed again with the volunteer's mouth open and closed. We will use two blenders taking gas flow from wall air and oxygen outlets (one for HFNC and one for CPAP). All trials will be run in room air oxygen concentration. All pressure measurement will be taken after each flow rate will be established for 15 min, to allow the volunteer to become accustomed to the feeling of different interfaces and to allow the breathing pattern to settle. All recordings will be taken over one minute of quiet breathing. The approximate total duration of the intervention will be around 1 hour. The different flow rate will be consecutively applied.

Sponsors

Federico Longhini
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

14 healthy volunteers (7 male and 7 female)

Exclusion criteria

contra-indications to pass a catheter into the pharynx (i.e., recent surgery or epistaxis)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026