Optimising mechanical ventilation in Intensive Care Unit (ICU)

Not Applicable

Recruiting

• Conditions: Acute respiratory distress syndrome (mild, moderate, severe); Respiratory failure patients requiring mechanical ventilation; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12614001069640
• Lead Sponsor: niversity of Canterbury

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-07
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength of mechanical ventilation (LoMV)[Duration of patients requiring mechanical ventilation from the time admitted to ICU to the time when patients is weaned.<br>];Area under the curve (AUC) of the Partial pressure of arterial blood oxygen (PaO2) over Fraction of inspired oxygen (FiO2) ratio (PF ratio). <br><br>Arterial blood gas is sampled daily and used. <br>FiO2 at the time when Arterial blood gas is sampled is recorded.<br><br>These information are used to calculate the PF ratio at the time when they were sampled.[Duration of patients requiring mechanical ventilation from the time admitted to ICU to the time when patients is weaned.];The number of Desaturation events measured as oxygen saturation measured by pulse oxymetry (SPO2) of less than 90%[Duration of patients requiring mechanical ventilation from the time admitted to ICU to the time when patients is weaned.]

Secondary Outcome Measures

Name	Time	Method
Area under the curve of the of Oxygen saturation measured using pulse oxymetry (SPO2) over Fraction of inspired oxygen (FiO2) ratio (SPO2/FiO2) <br><br>Hourly SPO2 and FiO2 are collected and recorded. These values are used to calculate the SPO2/FiO2 ratio at every hour.[Duration of patients requiring mechanical ventilation from the time admitted to ICU to the time when patients is weaned.];Chest X-ray Murray Index scores over time (subject to data availability: Chest X-ray may not be available) [Duration of patients requiring mechanical ventilation from the time admitted to ICU to the time when patients is weaned. <br><br>]