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A Study Into Noninvasive Ventilation and it's Impact on Lung Pressures at Different Ventilator Settings

A Study of Cardiac Surgical Patients Using Noninvasive Ventilation and it's impact on Mean Nasopharyngeal Airway Pressure at Different Pressure Settings

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000175370
Enrollment
12
Registered
2008-04-09
Start date
2008-04-09
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of this study is to investigate whether the pressure generated in the airway of a patient receiving noninvasive ventilation with a sealed face mask (used to assist breathing during respiratory failure / distress) is the same as the pressure generated in the mask. There is an assumption that the pressure in the mask is similar to the pressure in the airway. We think that it is likely to be lower in the airway due to resistance in the nose but the degree of difference will vary between individuals.

Interventions

Whilst participants (n=12) are still sedated following cardiac surgery, a 10F pressure catheter will be inserted into the nasopharynx via the nose. Once awake and extubated, participants will be commenced on face mask noninvasive ventilation. Once settled on the therapy the pressure catheter position will be confirmed using end tidal CO2 monitoring. Pressure measurements will then be carried out at three different pressure settings: 3, 5 and 7 cmH20 with mouth open and then repeated mouth closed

Whilst participants (n=12) are still sedated following cardiac surgery, a 10F pressure catheter will be inserted into the nasopharynx via the nose. Once awake and extubated, participants will be commenced on face mask noninvasive ventilation. Once settled on the therapy the pressure catheter position will be confirmed using end tidal CO2 monitoring. Pressure measurements will then be carried out at three different pressure settings: 3, 5 and 7 cmH20 with mouth open and then repeated mouth closed. Simultaneously, pressure in the face mask will recorded using a separate pressure catheter attached to a pressure monitoring port on the mask. The pressure catheter in the nasopharynx will be gently removed at the end of the study period. The measurements will take approximately 30mins to complete. The intervention is noninvasive ventilation at three different pressure settings. We are investigating the relationship between the pressure in the face mask and the pressure in the nasopharynx. We hypothesise that there is a difference between mask pressure and nasopharyngeal pressure and that this difference varies between patients.

Sponsors

Fisher and Paykel Healthcare
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Patients are eligible for inclusion if all of the following criteria are met: Consent has been obtained; The patient is 18 years or older; Consent has been obtained; The patient is undergoing cardiac surgery requiring sternotomy

Exclusion criteria

Patients will be excluded from the study if one or more of the following criteria are present: The patient has significant nasal septum deviation; Non-invasive ventilation is contraindicated; Following surgery the patient is unable to follow simple commands once awake and extubated

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026