Clinical trial NCT03790150: National Approach to Standardize and Improve Mechanical Ventilation
Official title: National Approach to Standardize and Improve Mechanical Ventilation Care for Critically Ill Patients in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Keywords: Ventilator-associated pneumonia
Mechanical Ventilation
Ventilator-associated events
Intensive care unit
Quality improvement project
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Saudi Arabia
First posted: 2018-12-31
Enrollment: 27966
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients

Brief summary: This is a pre-post implementation cohort study. This is a data driven quality improvement project which aims to improve the care of mechanically ventilated patients through the implementation of a bundle of evidence based practices, with a goal of reducing ventilator associated events and mortality.

Detailed description: NASAM is a national collaborative quality improvement project in Saudi Arabia which aims to:

1. Reduce the rate of ventilator-associated events
2. Improve the compliance with NASAM bundle elements
3. Reduce the mortality of mechanically ventilated patients

The plan of this quality improvement project is to extend the implementation to a total of 100 ICUs in collaboration with multiple health systems across the country. A significant component of this project includes measuring the safety culture of ICUs.

Eligibility criteria: Inclusion Criteria:

* All adult patients admitted to intensive care units

Exclusion Criteria:

* Age less than 14 years old

Primary outcomes:
measure: Ventilator-associated events
timeFrame: 18 months
Secondary outcomes:
measure: Sub-glottic endotracheal tube compliance rate
timeFrame: 18 months
measure: Head of bed elevation compliance rate
timeFrame: 18 months
measure: Spontaneous awakening trial (SAT) compliance rate
timeFrame: 18 months
measure: Percentage of ventilated patient days without sedation
timeFrame: 18 months
measure: Spontaneous breathing trials (SBT) compliance rate
timeFrame: 18 months
measure: Percentage of ventilated patient days without neuromuscular blockers
timeFrame: 18 months
measure: Percentage of out of bed mobility
timeFrame: 18 months
measure: Percentage of CAM-ICU negative (no delirium)
timeFrame: 18 months
measure: 90-day mortality
timeFrame: 90 days
measure: Mechanical ventilation duration
timeFrame: 90 days
measure: ICU length of stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs
city: Riyadh
country: Saudi Arabia
facility: King Abdullah International Medical Research Center
Study officials:
affiliation: King Abdullah Medical City, Ministry of National Guard Health Affairs
name: Yaseen M Arabi, MD
role: PRINCIPAL_INVESTIGATOR
References: