Clinical trial NCT05918172: 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
Official title: 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; A Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator-associated Pneumonia
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 168
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1 month to 18 years who required at least 48 hours of mechanical ventilation in picu

Brief 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.

Detailed 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)

Eligibility criteria: Inclusion Criteria:Pediatric patients aged 1 month to 18 years who required at least 48 hours of mechanical ventilation were included in the study before the 24th hour of intubation and mechanical ventilation -

Exclusion Criteria:history of intubation in the last 14 days, tracheomalacia secondary to trauma, stridor, suspected tracheal stenosis, refusal to participate in the study, presence of tracheotomy, mechanical ventilation for less than 48 hours, mechanical ventilation for more than 24 hours at PICU admission , suspected or diagnosed immunodeficiency, history of malignant disease (active or in remission), chronic pulmonary and/or heart disease, chronic other systemic diseases, and use of immunosuppressive medication (such as corticosteroids).

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Primary outcomes:
measure: Comparison of VIP incidences
timeFrame: january 2022 - january 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: IstanbulMU
state: Kadikoy
Study officials:
References:
citation: 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.
citation: 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.