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| Name | Class |
|---|---|
| Hamilton Medical AG | INDUSTRY |
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This prospective, randomized controlled cross-over study compares automatic (IntelliCuff®) and manual methods of endotracheal tube cuff pressure (CP) monitoring in pediatric intensive care patients. The study evaluates the frequency and duration of cuff pressure deviations outside the recommended range (15-25 cmH₂O) and assesses the impact on nursing workload.
Optimal cuff pressure management in pediatric patients undergoing mechanical ventilation is critical to prevent complications such as aspiration pneumonia or tracheal injuries. This study was designed to compare the effectiveness and safety of continuous automatic cuff pressure monitoring using the IntelliCuff® system versus standard manual cuff pressure monitoring performed by nurses every 2 hours.
Patients aged between 1 month and 18 years requiring invasive mechanical ventilation for at least 48 hours participated in a cross-over study at two tertiary pediatric intensive care units. Each patient underwent two consecutive 24-hour monitoring periods: one with automatic cuff pressure monitoring and another with manual monitoring. Data collected included the frequency and total duration of low (<15 cmH₂O) and high (>25 cmH₂O) pressure episodes, number of manual corrections required, and total nursing intervention time.
This study aims to determine whether automatic monitoring provides better control of cuff pressure, reduces the frequency of cuff-related complications, and decreases nursing workload compared to manual monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Cuff Pressure Monitoring | Active Comparator | In this arm, cuff pressure was manually measured and adjusted every 2 hours by nurses using a manometer, to maintain a target pressure between 15 and 25 cmH₂O over a 24-hour period. |
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| Automatic Cuff Pressure Monitoring | Experimental | In this phase, endotracheal tube cuff pressure was continuously monitored using the IntelliCuff® system (Hamilton Medical, Switzerland), which automatically adjusted the pressure to maintain it within the target range of 15-25 cmH₂O. Nurses intervened only if the system alerted due to a deviation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automatic Cuff Pressure Control | Device | he IntelliCuff® system (Hamilton Medical, Switzerland) continuously monitored and automatically adjusted cuff pressure to keep it within the target range of 15-25 cmH₂O. Manual intervention was only required upon system alert. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Time Spent Under Low Cuff Pressure | TTotal cumulative time (in hours) during which the endotracheal tube cuff pressure remained below 15 cmH₂O throughout the 24-hour monitoring period in each study phase. | 24 hours per intervention phase |
| Total Time Spent Under High Cuff Pressure | Total cumulative time (in hours) during which cuff pressure exceeded 25 cmH₂O in either monitoring method. | 24 hours per intervention phase |
| Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required | The number of times the cuff pressure had to be manually corrected due to deviations from the target range during each phase. | 24 hours per intervention phase |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nursing Intervention Time | Total time spent by nurses for cuff pressure monitoring and corrections, including routine checks and manual interventions. | 24 hours per intervention phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hasan Agin, Prof.Dr. | Dr. Behcet Uz Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydin Obstetric and pediatrics Hospital | Aydin | 09020 | Turkey (Türkiye) | |||
| Cam Sakura Research and Training Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33081526 | Background | Topjian AA, Raymond TT, Atkins D, Chan M, Duff JP, Joyner BL Jr, Lasa JJ, Lavonas EJ, Levy A, Mahgoub M, Meckler GD, Roberts KE, Sutton RM, Schexnayder SM; Pediatric Basic and Advanced Life Support Collaborators. Part 4: Pediatric Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S469-S523. doi: 10.1161/CIR.0000000000000901. Epub 2020 Oct 21. No abstract available. | |
| 26515515 |
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48 hours total (24 hours each phase, manual vs. automatic)
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|
| Istanbul |
| 34001 |
| Turkey (Türkiye) |
| Acibadem University, Acibadem Altunizade Hospital | Istanbul | Turkey (Türkiye) |
| The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital | Izmir | Turkey (Türkiye) |
| Result |
| Vottier G, Matrot B, Jones P, Dauger S. A cross-over study of continuous tracheal cuff pressure monitoring in critically-ill children. Intensive Care Med. 2016 Jan;42(1):132-3. doi: 10.1007/s00134-015-4103-8. Epub 2015 Oct 29. No abstract available. |
| 32376293 | Result | Dauvergne JE, Geffray AL, Asehnoune K, Rozec B, Lakhal K. Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study. Anaesth Crit Care Pain Med. 2020 Jun;39(3):435-441. doi: 10.1016/j.accpm.2020.04.007. Epub 2020 May 4. |
| 38528475 | Result | Zhu G, Wang X, Cao X, Yang C, Wang B, Ang Y, Duan M. The effect of different endotracheal tube cuff pressure monitoring systems on postoperative sore throat in patients undergoing tracheal intubation: a randomized clinical trial. BMC Anesthesiol. 2024 Mar 25;24(1):115. doi: 10.1186/s12871-024-02499-5. |
| 25425705 | Result | Chenelle CT, Oto J, Sulemanji D, Fisher DF, Kacmarek RM. Evaluation of an automated endotracheal tube cuff controller during simulated mechanical ventilation. Respir Care. 2015 Feb;60(2):183-90. doi: 10.4187/respcare.03387. Epub 2014 Nov 25. |
| 26471790 | Result | Alzahrani AR, Al Abbasi S, Abahoussin OK, Al Shehri TO, Al-Dorzi HM, Tamim HM, Sadat M, Arabi YM. Prevalence and predictors of out-of-range cuff pressure of endotracheal and tracheostomy tubes: a prospective cohort study in mechanically ventilated patients. BMC Anesthesiol. 2015 Oct 15;15:147. doi: 10.1186/s12871-015-0132-7. |