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

Ventilator-associated Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918172
• Other study ID #: 17334652306
• Status: Recruiting
• Start date: June 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Istanbul Medeniyet University
• Contact: AYSE ASIK
• Phone: 05533280449
• Email: drayseasik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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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Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Device:
• endotracheal cuff pressure manual measurement
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.
• endotracheal cuff pressure automatic measurement
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.

Locations

Country	Name	City	State
Turkey	IstanbulMU	Istanbul	Kadikoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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