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A study of the behavior of the lungs in critically ill patients to optimise treatment

A study to model the mechanical behavior of the lung in critically ill patients undergoing mechanical ventilation to determine the impact of different ventilation strategies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12611001179921
Enrollment
12
Registered
2011-11-14
Start date
2010-02-25
Completion date
2011-08-31
Last updated
2021-07-21

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 study will test current mathematical models of the lung mechanics (the way injured or damaged lungs move during ventilation) so the best possible ventilation strategy can be applied to each patient. The model estimates the lung condition. The final outcome is that the validated model can provide a fast diagnostic tool in the ICU that can be used to optimise treatment for individual patients.

Interventions

Having gained consent, patients will be sedated, or sedated and paralysed using muscle relaxants, to prevent spontaneous respiratory efforts. The patient’s initial ventilator settings- plateau pressure at end expiration (P plat), tidal volume (Vt), and positive end expiratory pressure (PEEP), will be recorded. All patients will be ventilated using volume controlled, synchronised intermittent mandatory ventilation (SIMV) while the study is being conducted. SIMV sets the tidal volume, with the ai

Having gained consent, patients will be sedated, or sedated and paralysed using muscle relaxants, to prevent spontaneous respiratory efforts. The patient’s initial ventilator settings- plateau pressure at end expiration (P plat), tidal volume (Vt), and positive end expiratory pressure (PEEP), will be recorded. All patients will be ventilated using volume controlled, synchronised intermittent mandatory ventilation (SIMV) while the study is being conducted. SIMV sets the tidal volume, with the airway pressure dependent on the patient’s condition. The tidal volume selected by the clinician treating the patient will not be changed for the duration of the measurements. However, if the patient is already on a pressure controlled mode of ventilation, the tidal volume is not directly set by the clinician. If a patient is on pressure controlled ventilation, they will be switched over to SIMV. The measured tidal volume of the pressure controlled mode will be then used to set the mandatory tidal volume of the SIMV mode. Patients who are spontaneous breathing will be trailed on SIMV and given additional sedation to synchronise their respiratory efforts with the ventilator. If necessary, a muscle relaxant may be added providing the patient is unaware of their surroundings. All patients in the study, while still mechanically ventilated will undergo a protocolised recruitment maneuver up to twice daily. Airway pressure and volume data from each maneuver will be collected. Heart rate, blood pressure and pulse oximetry will also be recorded to ensure there is no adverse impact on their circulation. During this maneuver, the airway pressure must be high enough to recruit most of the alveoli. However, if the peak airway pressure is too high, then there is a risk of over distending healthy alveoli and further injuring the lung. A target peak pressure of 45 cmH2O will be used. As the PEEP (Positive End Expiratory Pressure) is increased, the corresponding peak airway pressures also increase. However the increases in peak pressures are not predictable, and vary from patient to patient. To provide a safe trial for the patient, prior to the clinical protocol, a “practice protocol” will be performed to determine the maximum allowable PEEP (PEEPmax) that will produce a peak airway pressure of 45 cmH2O. Prior to the commencement of the protocol, a sample of blood will be taken to determine the arterial blood gas concentrations. This process is then repeated 30 minutes after the protocol is finished. The practice protocol will involve the clinician titrating PEEP until PEEPmax is achieved for the patient. Once PEEPmax is determined, then the clinician has an idea of the upper bound that the protocol can be carried out. Protocol 1. Pneumotachometer is attached to the ‘Y’ connector of the patient’s ventilation circuit. System is tested 2. Carry out PEEP titrations for practice protocol and determine PEEPmax 3. Apply 5 cm PEEP and carry out 5 PV loops with tidal volume of 500ml (or set to the patient’s previous setting, which ever is the lesser). This data will be captured. 4. This tidal volume will remain constant for the duration of the study. 5. Apply an additional 5 cm PEEP to the last PEEP used and carry out 5 PV loops. 6. Repeat step 5 until PEEPmax is achieved. 7. Trial Time (extra time required) = 11 – 17 minutes (Only PEEP titration), 41-47minutes (inclusion of arterial blood gas information). The observation will be carry out for 24 months.

Sponsors

University of Canterbury
Lead SponsorUniversity

Eligibility

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

Inclusion criteria

All recruited participants have acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). Patients with ALI have a P/F ratio 200-300 mmHg, and those with ARDS have a P/F ratio less than 200 mmHg. The P/F ratio is defined as the partial pressure of oxygen in the arterial blood divided by the fraction of inspired oxygen. The more severe the lung injury the lower this number.

Exclusion criteria

1. Patients who are improving and likely to be discontinued from mechanical ventilation within 24 hours 2. Patients who are not expected to survive. 3. Patients who are minimally sedated but oriented in either time or place or person. These patients are excluded because they will require additional sedation or relaxants to participate, which may cause additional inconvenience and prolong their length of stay.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 17, 2026