Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care

NCT05918172 | Completed

• 1 other identifier: 17334652306
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to compare manual (intermittent) versus automatic (continuous) endotracheal cuff pressure monitoring for the prevention of ventilator-associated pneumonia (VAP) in mechanically ventilated pediatric intensive care patients. The study was based on the hypothesis that maintaining endotracheal cuff pressure within the optimal range may reduce the incidence of VAP.

Conditions

Ventilator-associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Comparison of VIP incidences

  The comparison of the VIP incidence in the patients followed in the manual and automatic cuff pressure measurement groups was determined as the primary outcome.

  january 2022 - january 2024

Study Arms (2)

manual group

The cuff pressure of the tracheal tube will be monitored every 8 hours in the manual group using a portable manometer. The target endotracheal tube cuff pressure will be 20 cm H2O throughout the follow-up of the patients.

Device: endotracheal cuff pressure manual measurement

automatic group

The cuff pressure of the tracheal tube will be monitored continuously using a pneumatic device in the automatic group. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients.

Device: endotracheal cuff pressure automatic measurement

Interventions

endotracheal cuff pressure automatic measurement DEVICE

The cuff pressure of the tracheal tube will be monitored continuously using a pneumatic device in the automatic group. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. Before starting to work, PICU nurses will be given training in recognizing and preventing VAP and using cuff pressure measuring devices. The application period will continue from the day of intubation to extubation or a maximum of 14 days Study data forms will be filled out by PICU nurses and monitored by physicians. The research group will periodically observe PICU personnel to verify adherence to the protocol. While patients are mechanically ventilated, VIP findings will be routinely screened at each daily visit.

automatic group

endotracheal cuff pressure manual measurement DEVICE

The cuff pressure of the tracheal tube will be monitored every 8 hours in the manual group using a portable manometer. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. Before starting to work, PICU nurses will be given training in recognizing and preventing VAP and using cuff pressure measuring devices. The application period will continue from the day of intubation to extubation or a maximum of 14 days. Study data forms will be filled out by PICU nurses and monitored by physicians. The research group will periodically observe PICU personnel to verify adherence to the protocol. While patients are mechanically ventilated, VIP findings will be routinely screened at each daily visit.

manual group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

1 month to 18 years who required at least 48 hours of mechanical ventilation in picu

You may qualify if:

• Children aged 1 month to 18 years
• Intubated and mechanically ventilated patients expected to require at least 48 hours of mechanical ventilation
• Eligibility assessed and enrollment completed within 24 hours of intubation and initiation of mechanical ventilation

You may not qualify if:

• Previous intubation within 14 days before enrollment
• Already receiving mechanical ventilation for more than 24 hours at the time of PICU admission or screening
• Expected duration of mechanical ventilation less than 48 hours
• Presence of tracheostomy
• Trauma-related tracheomalacia
• Stridor
• Suspected or confirmed tracheal stenosis
• Suspected or confirmed immunodeficiency
• Current or previous malignancy
• Chronic pulmonary, cardiac, or other systemic disease
• Current use of immunosuppressive medications, including corticosteroids
• Declined consent / refusal to participate

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

IstanbulMU

Istanbul, Kadikoy, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• Marjanovic N, Boisson M, Asehnoune K, Foucrier A, Lasocki S, Ichai C, Leone M, Pottecher J, Lefrant JY, Falcon D, Veber B, Chabanne R, Drevet CM, Pili-Floury S, Dahyot-Fizelier C, Kerforne T, Seguin S, de Keizer J, Frasca D, Guenezan J, Mimoz O; AGATE Study Group. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study. Chest. 2021 Aug;160(2):499-508. doi: 10.1016/j.chest.2021.03.007. Epub 2021 Mar 13.

  PMID: 33727034 BACKGROUND

• Lorente L, Lecuona M, Jimenez A, Lorenzo L, Roca I, Cabrera J, Llanos C, Mora ML. Continuous endotracheal tube cuff pressure control system protects against ventilator-associated pneumonia. Crit Care. 2014 Apr 21;18(2):R77. doi: 10.1186/cc13837.

  PMID: 24751286 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Critical Care Fellow, Department of Pediatrics

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 10, 2024
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)