National Approach to Standardize and Improve Mechanical Ventilation

Completed

• Conditions: Mechanical Ventilation Complication
• Interventions: Other: Evidence-based practices

• Registration Number: NCT03790150
• Lead Sponsor: King Abdullah International Medical Research Center

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.

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Study Start: 2019-01-01
• Primary Completion: 2020-03-31
• Study Completion: 2021-03-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27966

Inclusion Criteria

• All adult patients admitted to intensive care units

Exclusion Criteria

• Age less than 14 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanically Ventilated Patients	Evidence-based practices	All patients admitted to the critical care unit and require mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Ventilator-associated events	18 months	Ventilator-associated events rate per 1000 ventilator days in 18 months

Secondary Outcome Measures

Name	Time	Method
Percentage of ventilated patient days without neuromuscular blockers	18 months	The percentage of ventilated patient days without neuromuscular blockers
Mechanical ventilation duration	90 days	The duration of mechanical ventilation in calendar days
Head of bed elevation compliance rate	18 months	The percentage of ventilator days with head of bed elevation ≥30 degrees
Percentage of CAM-ICU negative (no delirium)	18 months	The percentage of ventilator days with CAM-ICU negative (no delirium)
ICU length of stay	90 days	The number of calendar days from ICU admission to discharge from ICU
Sub-glottic endotracheal tube compliance rate	18 months	The percentage of ventilator days with sub-glottic endotracheal tube use
Spontaneous awakening trial (SAT) compliance rate	18 months	The percentage of ventilator days with spontaneous awakening trial (SAT)
Percentage of out of bed mobility	18 months	The percentage of ventilated patient days with out of bed mobility
90-day mortality	90 days	The 90-day ICU mortality rate of ventilated patients
Percentage of ventilated patient days without sedation	18 months	The percentage of ventilated patient days without sedation use
Spontaneous breathing trials (SBT) compliance rate	18 months	The percentage of ventilator days with spontaneous breathing trial (SBT)

Trial Locations

Locations (2)

Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs; 🇸🇦 Riyadh, Saudi Arabia

King Abdullah International Medical Research Center; 🇸🇦 Riyadh, Saudi Arabia