Mechanical Ventilation ComplicationNASAMNCT03790150
National Approach to Standardize and Improve Mechanical Ventilation
An observational study of Mechanical Ventilation Complication, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Evidence-based practices
- How many people
- 27,966 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 1 Jan 2019to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mechanically ventilated patients
Who may be able to join
- All adult patients admitted to intensive care units
Who cannot join
- Age less than 14 years old
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, 11426
King Abdullah International Medical Research Center
Riyadh, 22490
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Evidence-based practices
- Keywords
- Ventilator-associated pneumonia, Mechanical Ventilation, Ventilator-associated events, Intensive care unit, Quality improvement project
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based practicesOther
Implementation of evidence-based practices
| Study group | Role | What they receive |
|---|---|---|
| Mechanically Ventilated Patients | All patients admitted to the critical care unit and require mechanical ventilation Receives: Other: Evidence-based practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-associated events
Ventilator-associated events rate per 1000 ventilator days in 18 months
Measured: 18 months
Secondary outcomes (11)
Sub-glottic endotracheal tube compliance rate
The percentage of ventilator days with sub-glottic endotracheal tube use
Measured: 18 months
Head of bed elevation compliance rate
The percentage of ventilator days with head of bed elevation ≥30 degrees
Measured: 18 months
Spontaneous awakening trial (SAT) compliance rate
The percentage of ventilator days with spontaneous awakening trial (SAT)
Measured: 18 months
Percentage of ventilated patient days without sedation
The percentage of ventilated patient days without sedation use
Measured: 18 months
Spontaneous breathing trials (SBT) compliance rate
The percentage of ventilator days with spontaneous breathing trial (SBT)
Measured: 18 months
Percentage of ventilated patient days without neuromuscular blockers
The percentage of ventilated patient days without neuromuscular blockers
Measured: 18 months
Percentage of out of bed mobility
The percentage of ventilated patient days with out of bed mobility
Measured: 18 months
Percentage of CAM-ICU negative (no delirium)
The percentage of ventilator days with CAM-ICU negative (no delirium)
Measured: 18 months
90-day mortality
The 90-day ICU mortality rate of ventilated patients
Measured: 90 days
Mechanical ventilation duration
The duration of mechanical ventilation in calendar days
Measured: 90 days
ICU length of stay
The number of calendar days from ICU admission to discharge from ICU
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27,966 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Responsible party
- Principal investigator, Dr Yaseen Arabi, King Abdullah International Medical Research Center
- Investigators
- Yaseen M Arabi, MD, Principal investigator, King Abdullah Medical City, Ministry of National Guard Health Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790150
- Sponsor's protocol ID
- RC 17/223
- Acronym
- NASAM
- Status last verified
- Mar 2023
- First submitted
- 20 Dec 2018
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arabi YM, Al Aseri Z, Alsaawi A, Al Khathaami AM, Al Qasim E, Alzahrani AA, Al Qarni M, Abdukahil SAI, Al-Dorzi HM, Alattasi A, Mandourah Y, Alaama TY, Alabdulaali MK, Alqahtani A, Shuaibi A, Al Qarni A, Alkatheri M, Al Hazme RH, Vishwakarma RK, Aldibasi O, Alshahrani MS, Attia A, Alharthy A, Mady A, Abdelrahman BA, Mhawish HA, Abdallah HA, Al-Hameed F, Alghamdi K, Alghamdi A, Almekhlafi GA, Qasim SAH, Al Haji HA, Al Mutairi M, Tashkandi N, Alabbasi SO, Al Shehri T, Moftah E, Kalantan B, Matroud A, Naidu B, Al Zayer S, Burrows V, Said Z, Soomro NA, Yousef MH, Fattouh AA, Tahoon MA, Muhammad M, Alruwili AM, Al Hanafi HA, Dandekar PB, Ibrahim K, AlHomsi M, Al Harbi AR, Saleem A, Masih E, Al Rashidi NM, Amanatullah AK, Al Mubarak J, Al Radwan AAA, Al Hassan A, Al Muoalad S, Alzahrani AA, Chalabi J, Qureshi A, Al Ansari M, Sallam H, Elhazmi A, Alkhaldi F, Malibary A, Ababtain A, Latif A, Berenholtz SM; Saudi Critical Care Trials Group. Impact of a national collaborative project to improve the care of mechanically ventilated patients. PLoS One. 2023 Jan 30;18(1):e0280744. doi: 10.1371/journal.pone.0280744. eCollection 2023.
PubMed 36716310
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Approach to Standardize and Improve Mechanical Ventilation Care for Critically Ill Patients in Saudi Arabia
- ClinicalTrials.gov ID
- NCT03790150
- Acronym / sponsor ID
- NASAM / RC 17/223
- Conditions
- Mechanical Ventilation Complication
- Keywords
- Ventilator-associated pneumonia, Mechanical Ventilation, Ventilator-associated events, Intensive care unit, Quality improvement project
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,966 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated Patients | – | Other: Evidence-based practicesAll patients admitted to the critical care unit and require mechanical ventilation |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mechanically ventilated patients
Key inclusion criteria (1 listed)
- All adult patients admitted to intensive care units
Key exclusion criteria (1 listed)
- Age less than 14 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence-based practicesImplementation of evidence-based practices | Other | Mechanically Ventilated Patients |
Primary outcome
Ventilator-associated events
Time frame: 18 months
Ventilator-associated events rate per 1000 ventilator days in 18 months
11 secondary outcomes
Sub-glottic endotracheal tube compliance rate
Time frame: 18 months
Head of bed elevation compliance rate
Time frame: 18 months
Spontaneous awakening trial (SAT) compliance rate
Time frame: 18 months
Percentage of ventilated patient days without sedation
Time frame: 18 months
Spontaneous breathing trials (SBT) compliance rate
Time frame: 18 months
Percentage of ventilated patient days without neuromuscular blockers
Time frame: 18 months
Percentage of out of bed mobility
Time frame: 18 months
Percentage of CAM-ICU negative (no delirium)
Time frame: 18 months
90-day mortality
Time frame: 90 days
Mechanical ventilation duration
Time frame: 90 days
ICU length of stay
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 36716310Arabi YM, Al Aseri Z, Alsaawi A, Al Khathaami AM, Al Qasim E, Alzahrani AA, Al Qarni M, Abdukahil SAI, Al-Dorzi HM, Alattasi A, Mandourah Y, Alaama TY, Alabdulaali MK, Alqahtani A, Shuaibi A, Al Qarni A, Alkatheri M, Al Hazme RH, Vishwakarma RK, Aldibasi O, Alshahrani MS, Attia A, Alharthy A, Mady A, Abdelrahman BA, Mhawish HA, Abdallah HA, Al-Hameed F, Alghamdi K, Alghamdi A, Almekhlafi GA, Qasim SAH, Al Haji HA, Al Mutairi M, Tashkandi N, Alabbasi SO, Al Shehri T, Moftah E, Kalantan B, Matroud A, Naidu B, Al Zayer S, Burrows V, Said Z, Soomro NA, Yousef MH, Fattouh AA, Tahoon MA, Muhammad M, Alruwili AM, Al Hanafi HA, Dandekar PB, Ibrahim K, AlHomsi M, Al Harbi AR, Saleem A, Masih E, Al Rashidi NM, Amanatullah AK, Al Mubarak J, Al Radwan AAA, Al Hassan A, Al Muoalad S, Alzahrani AA, Chalabi J, Qureshi A, Al Ansari M, Sallam H, Elhazmi A, Alkhaldi F, Malibary A, Ababtain A, Latif A, Berenholtz SM; Saudi Critical Care Trials Group. Impact of a national collaborative project to improve the care of mechanically ventilated patients. PLoS One. 2023 Jan 30;18(1):e0280744. doi: 10.1371/journal.pone.0280744. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaseen M Arabi, MD principal investigator
King Abdullah Medical City, Ministry of National Guard Health Affairs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-associated events (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.