Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02838160
Other study ID # VAP BMSU
Secondary ID
Status Completed
Phase N/A
First received July 17, 2016
Last updated July 19, 2016
Start date October 2011
Est. completion date June 2015

Study information

Verified date July 2016
Source Baqiyatallah Medical Sciences University
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics CommitteeIran: Ministry of Health
Study type Interventional

Clinical Trial Summary

A randomized controlled triple blinded clinical trial with repeated measurements. The reporting of this study complies with the CONSORT (Consolidated Standards of Reporting Trials) statement for trials of non-pharmacological treatments.

The first aim of the study was to evaluate the effectiveness of the three competing interventions on the critical care nurses' knowledge of, attitudes toward and adherence to 17 ventilator bundle components; the second aim was to determine the effectiveness of adherence to 17 ventilator bundle components with pre-defined ventilator bundle on the psychological factors of critical care nurses including nurses' stressors in intensive care unit (ICU), perceived stress, trait and state anxieties; the third aim was to evaluate their impact on the clinical outcomes; and the fourth aim was comparing KAP and psychological factors with clinical outcomes.


Description:

The multi-center study was conducted in four academic teaching hospitals in Tehran, Iran. The study consisted of a 3-month baseline observation period (October 2011-December 2011, Period 1), followed by a 6-month intervention period (January 2012 to June 2012) and a 3 (July 2012-September 2012, Period 2), 15 (October 2012-December 2013, Period 3) and 21-months (January 2014-June 2015, Period 4) follow-up periods. The protocol for Evidence based guidelines (EBGs) for preventing VAP remained unchanged throughout the study period in every ICU.

Consecutive adult patients (age ≥18 years) who were admitted to the mixed medical-surgical ICUs (>72 hours) and received invasive ventilation (>48 hours) were enrolled and monitored daily for the development of ventilator-associate pneumonia (VAP) until ICU discharge or death. Patients with any limitation of code status were excluded from the study. Convenience sample of critical care nurses were recruited through letters and telephone and face-to-face invitations. Inclusion criteria were holding a degree qualification as a registered nurse and being a direct care provider (bedside). Nurses with less than one year experience in critical care unit or working less than whole study period were excluded. An investigator at each participating medical center was responsible for initial screening and enrollment.

The sample size was determined through power analysis, which revealed that a sample size of 40 participants was required to detect a 20% difference between VAP rates in each group (α = 0.05, 1-β = 0.9; dropout = 20%). The estimation of the effect size based on a previous VAP surveillance, conducted from March 2010 to December 2010 (unpublished data).

Included nurses were randomly assigned to control or one of the three competing intervention group (allocation ratio of 1:4). Randomization was accomplished using Random Allocation Software© (RAS; Informer Technologies, Inc.). Block randomization was performed by a computer-generated randomization list prepared by blinded biostatistician who had no clinical involvement in the trial. All nurses, data collectors, and statistician were blinded to group assignment.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Holding a degree qualification as a registered nurse

- being a direct care provider (bedside)

Exclusion Criteria:

- Nurses with less than one year experience in critical care unit

- working less than whole study period were excluded

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Behavioral:
Routine Care
After baseline measurement, Group 1 did not receive any intervention or education.
Routine care Plus the designed booklet
Group 2 received only the designed booklet without any participation in the oral presentation.
Routine care Plus the designed booklet Plus participation in oral presentations
Group 3 participated in oral presentations 14 days after completing self-study booklet. Interactive, standardized and mandatory oral presentations were held five times to ensure maximum attendance of the three nursing shifts.
Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedside
The Group 4 received clinical teaching in bedside after completing self-study booklet and a series of interactive, standardized and mandatory 90-120-minute oral presentations.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Baqiyatallah Medical Sciences University Shahid Beheshti University, Tehran University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary VAP Occurrence VAP Occurrence according to the clinical sings and symptoms and laboratory tests One year Yes
See also
  Status Clinical Trial Phase
Completed NCT01406951 - Diagnostic Value of sTREM-1 and PCT Level as Well as CPIS Score for Ventilator-Associated Pneumonia Among ICU Sepsis Patients N/A
Completed NCT00893763 - Strategies To Prevent Pneumonia 2 (SToPP2) Phase 2
Recruiting NCT03581370 - Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients With Ventilator Associated-pneumonia Phase 3
Completed NCT02070757 - Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008) Phase 3
Completed NCT03348579 - Hospital-acquired Pneumonia in Intensive Care Unit
Completed NCT04242706 - VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs Phase 4
Recruiting NCT05589727 - Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil
Not yet recruiting NCT06168734 - Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP Phase 3
Completed NCT02515448 - A Pharmacokinetic-pharmacodynamic Dose Comparison Study of 8 mg/kg of Inhaled or Parenteral Gentamicin in 12 Mechanically Ventilated Critically Ill Patients Treated for Ventilator-associated Pneumonia Phase 1
Completed NCT01972425 - Biomarker-based Exclusion of VAP for Improved Antibiotic Stewardship N/A
Completed NCT01467648 - The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia Phase 4
Completed NCT00364299 - Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure N/A
Not yet recruiting NCT03018431 - CT Scan and Lung Ultrasonography to Improve Diagnostic of Ventilation Acquired Pneumonia in ICU N/A
Completed NCT02515617 - Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER) N/A
Completed NCT02583308 - Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation N/A
Completed NCT02585180 - Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia N/A
Recruiting NCT01546974 - Ventilator-associated Pneumonia (VAP) and Humidification System Phase 4
Completed NCT02060045 - Prevention Ventilator Associated Pneumonia N/A
Terminated NCT00543608 - Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia Phase 2
Completed NCT02116699 - Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360) N/A