National Approach to Standardize and Improve Mechanical Ventilation (NASAM)

National Approach to Standardize and Improve Mechanical Ventilation Care for Critically Ill Patients in Saudi Arabia

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Other: Evidence-based practices

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 Type: Observational
• Enrollment (Actual): 27966

Contacts and Locations

• Study Contact: Name: Yaseen M Arabi, MD; Phone Number: 18855/18877 8011111; Email: arabi@ngha.med.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11426
    • Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs
  • Riyadh, Saudi Arabia, 22490
    • King Abdullah International Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients

Description

Inclusion Criteria:

• All adult patients admitted to intensive care units

Exclusion Criteria:

• Age less than 14 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanically Ventilated Patients; All patients admitted to the critical care unit and require mechanical ventilation	Other: Evidence-based practices; Implementation of evidence-based practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator-associated events	Ventilator-associated events rate per 1000 ventilator days in 18 months	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Collaborators: Ministry of Health, Saudi Arabia
• Investigators: Principal Investigator: Yaseen M Arabi, MD, King Abdullah Medical City, Ministry of National Guard Health Affairs

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Intensive care unit; Mechanical Ventilation; Ventilator-associated pneumonia; Ventilator-associated events; Quality improvement project
• Other Study ID Numbers: RC 17/223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No