Clinical Trials Logo

Clinical Trial Summary

Based on the hypothesis that keeping the endotracheal cuff pressure in the optimum range will reduce the incidence of vip, we aimed to compare the Manual (intermittent) measurement method with the Automatic (continuous) measurement method in reducing the incidence of vap.


Clinical Trial Description

Ventilator-associated pneumonia (VIP) is a major cause of morbidity and mortality in intensive care patients. Microaspiration of oropharyngeal and gastric secretions contaminated with bacteria is one of the important factors contributing to the formation of VIP. Under- or over-inflation of the endotracheal tube balloon (cuff) can lead to micro-aspiration, VIP development, and tracheal damage. Intermittent (manual) or continuous (automatic) control of the endotracheal tube cuff pressure has been used as a strategy for preventing VIP in recent years. There are few adult studies evaluating the effectiveness of the use of manual and automatic cuff gauges in intensive care patients in preventing the development of VIP. Our study is the first randomized controlled study in the literature to evaluate the effectiveness of two methods in preventing the development of VIP in pediatric intensive care patients. Our study is a randomized controlled single-blind clinical study. It was planned to include patients aged between 1 month and 18 years, who required at least 48 hours of mechanical ventilation. Our exclusion criteria; intubation history in the last 14 days, airway trauma, airway anomaly, tracheotomy, mechanical ventilation for less than 48 hours and immunosuppression. It was planned to include the patients included in the study in the manual or automatic cuff gauge group using a 1:1 randomization table. In the automatic cuff meter group, it was planned to monitor the patients continuously by targeting 20 cmH20 endotracheal tube pressure. It was planned to measure the cuff pressure at 8 hour intervals for the patients in the manual cuff gauge group and to correct the deviations in the pressure. CDC criteria will be used as VIP diagnostic criteria. Patients will be monitored for the development of VIP and complications related to the endotracheal tube (such as stenosis, stridor) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05918172
Study type Observational [Patient Registry]
Source Istanbul Medeniyet University
Contact AYSE ASIK
Phone 05533280449
Email drayseasik@gmail.com
Status Recruiting
Phase
Start date June 2023
Completion date June 2024

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 NCT02838160 - Effectiveness of Different Educational Strategies on the KAP, Psychological and Clinical Outcomes 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 NCT02585180 - Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia N/A
Completed NCT02583308 - Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation 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