Skip to content

Optimising mechanical ventilation in Intensive Care Unit (ICU)

The effect of Model-based positive end expiratory pressure (PEEP) selection compared to standard practice PEEP selection in the length of mechanical ventilation of respiratory failure patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001069640
Acronym
Clinical Utilisation of Respiratory Elastance: the 'CURE' Study - Optimising PEEP in people on mecha
Enrollment
9
Registered
2014-10-07
Start date
2016-05-06
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

None listed

Brief summary

Intensive care clinicians use Mechanical Ventilation on a daily basis in the ICU to treat patients with injured lungs. An important setting on the ventilator machines is known as positive end expiratory pressure or PEEP. This controls the pressure in the lung at the end of the breath, and its accuracy is critical in the successful treatment of injured lungs. Currently, doctors have no standard way of selecting the PEEP for each patient, and use their clinical intuition, or their “gut-feeling”. Different patients have different lungs and as such, selecting PEEP this way might lead to an incorrect PEEP setting for that patient. This might cause the patient to require longer stays in the ICU and/or or further lung injury. This study aims to evaluate a computer based method of PEEP selection by in a randomised control trial (RCT). A RCT involves a random allocation for your relative or friend under mechanically ventilation to either A) receive standard treatment or B) receive standard treatment with the aid to potentially improve their recovery. The RCT is based on prior research conducted here in the Christchurch ICU. Because this method of PEEP selection is specific to each patient, it is anticipated ventilation better matched to their lungs. This could lead to healthier lungs and as a result, require the patient to spend less time in the ICU.

Interventions

Clinical Protocol Patients who meet the inclusion criteria will be randomised to intervention or control Patients’ data on both arms will be monitored. Patients on the intervention will have their ventilation PEEP setting being guided by the bedside computer using the pulmonary elastance model. Patients will undergo Maximum Recruitment Manoeuvre (MaxRM) or PEEP adjustment and Monitoring Procedure (PUMP). MaxRM and PUMP are step-wise PEEP change recruitment manoeuvres (RM). During the RM, PEEP

Clinical Protocol Patients who meet the inclusion criteria will be randomised to intervention or control Patients’ data on both arms will be monitored. Patients on the intervention will have their ventilation PEEP setting being guided by the bedside computer using the pulmonary elastance model. Patients will undergo Maximum Recruitment Manoeuvre (MaxRM) or PEEP adjustment and Monitoring Procedure (PUMP). MaxRM and PUMP are step-wise PEEP change recruitment manoeuvres (RM). During the RM, PEEP will be adjusted by steps of increase and decrease and the pulmonary elastance of the patient at each PEEP is calculated using the bedside computer. The protocol will ideally be run for at least 48 hours, and discontinued at the discretion of the clinician when patient lung condition has significantly improved. Data collection will continue until patient is discontinued from mechanical ventilation. Patient Preparation 1. For the length of mechanical ventilation, patients will be randomised to Control or Intervention using a block randomisation software. 2. For patients randomised for control, they will receive current standard of care of the participating centre. 3. For patients included for intervention, the PEEP and MV will be guided by clinicians using bedside computers. (i) All patients in the intervention are ventilated using (i) Puritan Bennett PB840 ventilator (Covidien, Boulder, CO, USA) or (ii) Draeger V500 ventilator (Dragerwerk AG & Co. Lubeck, Germany) or (iii) Hamilton Medical G5 ventilator (Bonaduz, Switzerland) using synchronized intermittent mandatory ventilation (SIMV) with volume control while maintaining tidal volume and FiO2 similar to the control group. (ii) Before the RM, patients may be sedated and paralyzed with muscle relaxants to prevent spontaneous breathing efforts. (iii) The first RM when the patient is included in the study is a maximum recruitment manoeuvre (MaxRM). This is done at the beginning of the trial by clinicians and only repeated if clinically indicated. Other PEEP adjustments will be a modification of the MaxRM. The PEEP Adjustment and Monitoring Procedure is referred to as a ‘PUMP’, where the change of PEEP is -2 cmH2O to 6 cmH2O of the current PEEP setting The PUMP may be performed by either medical or nursing staff trained in the technique. (iv) The PEEP adjustment will stop a. When weaning from mechanical ventilation is considered appropriate, and b. The patient has transitioned to spontaneous breathing; defined as when the respiratory rate is set to equal or less than 10 breaths per minute and c. Patient's FiO2 equal or less than 35% and d. Arterial blood oxygen, PaO2 equal or more than 60mmHg at FiO2 equal or less than 35% for the last 24 hours. e. After 10 days from study enrolment. f. At the discretion of the clinician when the patient's lung injury is no longer thought to be delaying their recovery. 4. Data will be collected continuously until the patient is disconnected from the ventilator. Maximum Recruitment Manoeuvre (MaxRM) Patients randomised into intervention will immediately receive the following intervention: 1. Patient airway cuff pressure will be increased to 50 cmH2O to prevent leaks during maximum recruitment manoeuvre (MaxRM). 2. The peak airway pressure alarm on the ventilator is set to 55 cmH2O. 3. Prior to the MaxRM, a muscle relaxant with appropriate sedation (eg. fentanyl and/ or propofol) are co-administered. 4. During the MaxRM, PEEP is initially increased in steps of 4 cmH2O above the baseline PEEP level (selected by clinicians) until Peak airway pressure reaches (PIP) equal or more than 45 cmH2O and thereafter, in 2 cmH2O until PIP equal or more than 50 cmH2O. 5. Each PEEP is maintained for 10-15 breathing cycles for calculation of Elastance before a subsequent PEEP increase. 6. After reaching PIP of equal or more than 50 cmH2O, PEEP is reduced by 4 cmH2O steps until initial PEEP setting. 7. Once PEEP has returned to the initial setting, a second RM is performed with PEEP increase steps of 4 cmH2O to the same PIP used in the first RM. PEEP is then decreased by steps of 2 cmH2O until the optimal PEEP level has been obtained. This PEEP will be recommended by bedside computer when the elastance decrement is e equal or less than 5% of the previous value. 8. If the intensive care clinicians do not feel the recommended PEEP level is appropriate, they will have the discretion to select a PEEP of their choice. The clinician will be prompted to record the reasons they have not followed the recommendation. 9. This process will be performed at the beginning of the trial, and only repeated at the clinician’s discretion, e.g. if there has been a possible loss of recruitment following a disconnection from the ventilator. 10. At the end of the MaxRM, the cuff pressure is reduced back to ~30 cmH2O and the ventilator high pressure alarm is set to back to initial setting. PEEP adjustment and Monitoring Procedure (PUMP) This procedure is performed when: i. The patient is turned to supine position or ii. Every subsequent 6 hours after the first RM or iii. If the FiO2 is increased by equal or more than 10% or iv. Anytime at the clinician's discretion Whichever of (i) –(iv) occurs first triggers a PUMP procedure. *Usual clinical practice is to turn patients left side to supine to right side every three hours The procedure for the above PEEP adjustment and monitoring manoeuvres (PUMPs) are as follows: 1. PEEP is first decreased by 2 cmH2O and increased in 2 steps of 4 cmH2O with 10-15 breathing cycles at each step before decreasing back in 4 cmH2O decrements to -2 cmH2O of baseline PEEP. 2. Step 1 is immediately repeated, except the PEEP is reduced in 2 cm decrements. 3. The Bedside computer will recommend the optimal PEEP, at a PEEP higher than minimal elastance at the end of the second PUMP Recruitment Manoeuvre. 4. If the intensive care clinicians do not feel the recommended PEEP level is appropriate, they will have the discretion to select a PEEP of their choice. The clinician will be prompted to record the reasons they have not followed the recommendation.

Sponsors

University of Canterbury
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

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

Inclusion criteria

1. Patients requiring invasive mechanical ventilation (MV) (Intubation or tracheotomy). 2. Patients diagnosed with all acute respiratory distress syndrome (ARDS) severity (PF [oxygen partial pressure to fraction of inspired oxygen] ratio <300mmHg) as per the Berlin Definition (The ARDS Definition Task Force, A. 2012), by intensive care clinicians. 3. Arterial line in situ.

Exclusion criteria

1. Patients who are likely to be discontinued from MV within 24 hours. 2. Patients with age <16. 3. Patients who have moderate or severe traumatic brain injury, and/or a measured intracranial pressure equal or more than 20 cmH2O. 4. Any medical condition associated with a clinical suspicion of raised intracranial pressure. 5. Patients who have a high spinal cord injury with loss of motor function. 6. Patients who have significant weakness from any neurological disease. 7. Patients who have a Barotrauma (pneumothorax, pneumomediastinum, subcutaneous emphysema or any intercostal catheter for the treatment of air leak). 8. Patients who have asthma as the primary presenting condition or a history of significant chronic obstructive pulmonary disease. 9. Patients who are moribund and/or not expected to survive for > 72 hours. 10. Patients who are pregnant. 11. Patients who have already received MV for >48 hours (including time spent ventilated in a referring unit). 12. Lack of clinical equipoise by intensive care unit (ICU) medical staff managing the patient. 13. Patients readmitted to ICU within 28 days of the first day entered into the study. 14. Patients readmitted to ICU at any time if they have participated in the study during the same hospital admission. ** Termination criteria for the recruitment manoeuvres During a recruitment manoeuvre (RM), there are known impacts on the cardiovascular system and respiratory system. Specifically, there is a fall in cardiac output, or blood pressure, or desaturation due to increases of pulmonary shunt. These changes will be anticipated and, inotropes, fluid loading and oxygen therapies maybe initiated to these changes in advance of the RM. A) Recruitment manoeuvre will not be initiated if the patient care may be compromised from increased sedation and/or use of muscle relaxants. B) At any time during a recruitment manoeuvre, the RM is terminated if any of the changes below persist for more than 3 minutes: 1. Desaturation with SPO2 less than 88%. 2. New bradycardia (reduction heart rate by 20% and < 60 beats per minute) or, 3. New tachycardia (increase of heart rate by 20% and > 140 beats per minute) or, 4. New arrhythmia leading to (a) or (b) above or, 5. New hypotension (reduction in MAP by 30% or MAP < 60mmHg). C) Lack of clinical equipoise by the clinician; e.g. when a patient has a low blood pressure and is thought to be intolerant of PEEP changes. Intervention will be stopped and will revert to current standard of care when there is lack of clinical equipoise by the clinician. The clinical reason will be recorded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 28, 2026