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NCT Number: NCT03790150

National Approach to Standardize and Improve Mechanical Ventilation

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.

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Key information

Conditions

Mechanical Ventilation Complication Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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

  • Reduce the rate of ventilator-associated events
  • Improve the compliance with NASAM bundle elements
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult patients admitted to intensive care units

Exclusion criteria

  • Age less than 14 years old

Treatment and study plan

Evidence-based practices

Other

Implementation of evidence-based practices

Primary outcomes

  1. Ventilator-associated events

    Time frame: 18 months

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

Secondary outcomes

  1. Sub-glottic endotracheal tube compliance rate

    Time frame: 18 months

    The percentage of ventilator days with sub-glottic endotracheal tube use

  2. Head of bed elevation compliance rate

    Time frame: 18 months

    The percentage of ventilator days with head of bed elevation ≥30 degrees

  3. Spontaneous awakening trial (SAT) compliance rate

    Time frame: 18 months

    The percentage of ventilator days with spontaneous awakening trial (SAT)

  4. Percentage of ventilated patient days without sedation

    Time frame: 18 months

    The percentage of ventilated patient days without sedation use

  5. Spontaneous breathing trials (SBT) compliance rate

    Time frame: 18 months

    The percentage of ventilator days with spontaneous breathing trial (SBT)

  6. Percentage of ventilated patient days without neuromuscular blockers

    Time frame: 18 months

    The percentage of ventilated patient days without neuromuscular blockers

  7. Percentage of out of bed mobility

    Time frame: 18 months

    The percentage of ventilated patient days with out of bed mobility

  8. Percentage of CAM-ICU negative (no delirium)

    Time frame: 18 months

    The percentage of ventilator days with CAM-ICU negative (no delirium)

  9. 90-day mortality

    Time frame: 90 days

    The 90-day ICU mortality rate of ventilated patients

  10. Mechanical ventilation duration

    Time frame: 90 days

    The duration of mechanical ventilation in calendar days

  11. ICU length of stay

    Time frame: 90 days

    The number of calendar days from ICU admission to discharge from ICU

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Collaborators

  • Ministry of Health, Saudi Arabia

Registry information

Official study title

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

Acronym: NASAM

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Dec 31, 2018
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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