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A Multi-centre Observational study of Supportive Ventilation Adjustments and Respiratory Effort Parameters in Adult Patients Admitted to the Intensive Care Unit

An Audit of Supportive Ventilation Adjustments and Respiratory Effort Parameters in Adults Admitted to the Intensive Care Unit

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623001251617
Enrollment
1
Registered
2023-12-04
Start date
2023-12-05
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

Many patients admitted to the intensive care unit (ICU) for on-going clinical management receive breathing assistance with machines (mechanical ventilation). Mechanical ventilation is the process by which a patient’s breathing is supported by a ventilator. Broadly speaking there are two modes of breathing: i) Mandatory and ii) Supportive. Mandatory ventilation is used when the clinicians deem it necessary to control all aspects of breathing. Supportive ventilation is used when the clinicians aim to help the patient’s spontaneous breathing with some adjusted machine assistance. While receiving mechanical ventilation the patient’s intensive care clinicians make clinical decisions about their patient’s breathing. Such decisions relate to the amount of oxygen to provide, the number and depth of breaths, how much force is needed to adequately inflate the lungs and importantly when it is suitable to wake the patient and remove the breathing tube. All these decisions can be defined as the ventilation management of the critically ill patient receiving mechanical ventilation. For critically ill patients, changes in ventilation support are often made based breathing rate (respiratory rate) and size of breaths (tidal volume). However, the effect these changes have on measurable aspects of breathing effort (which define breathing work) remain unclear. Importantly, such information, which was difficult to get in the past, can now be obtained from modern ventilators just by pushing a button or moving a cursor on the screen. Such information is then displayed on the ventilator screen. In response, we will perform a prospective observational study of supportive ventilation settings in patients who are receiving supportive mechanical ventilation in the intensive care unit. In this multi-centre study, we estimate that the information obtained from 30-35 patients per site (4 sites) will lead to approximately 900 ventilation data-points collected from a cohort of 100 patients.

Interventions

Twice daily auditing between 08:00-10:00 and 16:00-18:00 to identify mechanically ventilated patients in spontaneous ventilation modes, in order to observe clinicians as they adjust the level of pressure support to optimise respiratory rate and tidal volume, typically applying the usual rates of 5, 10 or 15 cm of H2O of pressure support and observing the changes in respiratory rate and tidal volume. Observations will be undertaken twice daily for a maximum of seven consecutive days by study team

Twice daily auditing between 08:00-10:00 and 16:00-18:00 to identify mechanically ventilated patients in spontaneous ventilation modes, in order to observe clinicians as they adjust the level of pressure support to optimise respiratory rate and tidal volume, typically applying the usual rates of 5, 10 or 15 cm of H2O of pressure support and observing the changes in respiratory rate and tidal volume. Observations will be undertaken twice daily for a maximum of seven consecutive days by study team members. Clinicians will be informed of the observations and the ventilation management of patients will remain at the discretion of the treating clinicians.

Sponsors

Austin Health
Lead SponsorHospital

Eligibility

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

Inclusion criteria

All adult patients, aged equal to or greater than 18 years, who requiring mechanical ventilation in a spontaneous ventilation mode while admitted to the intensive care unit as identified during the twice daily screening periods. Patients are to have had less than or equal to 24 hours of pressure support ventilation at the time of assessment and be expected to receive mechanical ventilation until the day after tomorrow.

Exclusion criteria

All adult patients requiring mechanical ventilation who are not in a spontaneous ventilation mode while admitted to the intensive care unit as identified during the twice daily screening periods. Patients with neuromuscular disease, spinal cord injury. Received neuromuscular blockage medication in the previous 12 hours, are deeply sedated (as assessed by the Richmond Agitation-Sedation Scale (RASS) score 3 or less, e.g. unresponsive to voice) who are in a mandatory mode of ventilation, and pregnancy will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026