NCT03790150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27,966

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

December 20, 2018

Last Update Submit

March 12, 2023

Conditions

Mechanical Ventilation Complication

Keywords

Ventilator-associated pneumoniaMechanical VentilationVentilator-associated eventsIntensive care unitQuality improvement project

Outcome Measures

Primary Outcomes (1)

  • Ventilator-associated events

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

    18 months

Secondary Outcomes (11)

  • Sub-glottic endotracheal tube compliance rate

    18 months

  • Head of bed elevation compliance rate

    18 months

  • Spontaneous awakening trial (SAT) compliance rate

    18 months

  • Percentage of ventilated patient days without sedation

    18 months

  • Spontaneous breathing trials (SBT) compliance rate

    18 months

  • +6 more secondary outcomes

Study Arms (1)

Mechanically Ventilated Patients

All patients admitted to the critical care unit and require mechanical ventilation

Other: Evidence-based practices

Interventions

Evidence-based practicesOTHER

Implementation of evidence-based practices

Mechanically Ventilated Patients

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mechanically ventilated patients

You may qualify if:

  • All adult patients admitted to intensive care units

You may not qualify if:

  • Age less than 14 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Riyadh, 11426, Saudi Arabia

Location

King Abdullah International Medical Research Center

Riyadh, 22490, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 36716310DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yaseen M Arabi, MD

    King Abdullah Medical City, Ministry of National Guard Health Affairs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Intensive Care Unit

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 31, 2018

Study Start

January 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2021

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SA(2)