National Approach to Standardize and Improve Mechanical Ventilation

Mechanical Ventilation Complication Clinical Trial

— NASAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790150
• Other study ID #: RC 17/223
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2023
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27966
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• All adult patients admitted to intensive care units

Exclusion Criteria:

• Age less than 14 years old

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Other:
• Evidence-based practices
Implementation of evidence-based practices

Locations

Country	Name	City	State
Saudi Arabia	Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs	Riyadh
Saudi Arabia	King Abdullah International Medical Research Center	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center	Ministry of Health, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-associated events	Ventilator-associated events rate per 1000 ventilator days in 18 months	18 months
Secondary	Sub-glottic endotracheal tube compliance rate	The percentage of ventilator days with sub-glottic endotracheal tube use	18 months
Secondary	Head of bed elevation compliance rate	The percentage of ventilator days with head of bed elevation =30 degrees	18 months
Secondary	Spontaneous awakening trial (SAT) compliance rate	The percentage of ventilator days with spontaneous awakening trial (SAT)	18 months
Secondary	Percentage of ventilated patient days without sedation	The percentage of ventilated patient days without sedation use	18 months
Secondary	Spontaneous breathing trials (SBT) compliance rate	The percentage of ventilator days with spontaneous breathing trial (SBT)	18 months
Secondary	Percentage of ventilated patient days without neuromuscular blockers	The percentage of ventilated patient days without neuromuscular blockers	18 months
Secondary	Percentage of out of bed mobility	The percentage of ventilated patient days with out of bed mobility	18 months
Secondary	Percentage of CAM-ICU negative (no delirium)	The percentage of ventilator days with CAM-ICU negative (no delirium)	18 months
Secondary	90-day mortality	The 90-day ICU mortality rate of ventilated patients	90 days
Secondary	Mechanical ventilation duration	The duration of mechanical ventilation in calendar days	90 days
Secondary	ICU length of stay	The number of calendar days from ICU admission to discharge from ICU	90 days