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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
| Afyonkarahisar Health Sciences University Hospital | UNKNOWN |
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The purpose of study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents.
In the study, ET cuff pressure control will be provided with pilot balloon fingers (Control Group), intermittent with a manometer (Study Group 1) and continuously with a smart cuff manager (Study Group 2).
To assess the effect of different ETT cuff pressure control on microaspiration of the stomach contents, the pepsin level will be measured during deep tracheal secretions. The samples will be examined in the first four hours after intubation, all secretions collected up to the 24th hour of intubation after first sample intake and all secretions collected between 24-48 hours after intubation. Pepsin level will be considered as positive for cut-off point. In addition, the effect of different ETT cuff pressures control on the incidence of VAP will be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Endotracheal Cuff Pressure Control | Experimental | Continuous endotracheal cuff pressure control using smart cuff manager during the first 48 hours of intubation in the intensive care unit |
|
| Intermittent Endotracheal Cuff Pressure Control | Experimental | Intermittent cuff pressure control through manual manometer measurement performed 3 times per day during the first 48 hours of intubation in the intensive care unit |
|
| Standard Care | No Intervention | ET cuff pressure control will be provided with pilot balloon fingers during the first 48 hours of intubation in the intensive care unit |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Cuff Manager | Device | Participant will be attached to the smart cuff manager within 4 hours after intubation. They will remain attached during the first 48 hours of intubation in the intensive care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Microaspiration of Gastric Contents | The unintentional aspiration of very small amounts of gastric contents | From randomisation to 48 hours after intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Özlem SOYER | Afyonkarahisar | Center | 03200 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36002981 | Derived | Er OS, Van Giersbergen MY, Celik S. Effects of three endotracheal tube cuff pressure control measures on microaspiration of gastric content: Study protocol for randomised controlled trial. J Clin Nurs. 2023 Apr;32(7-8):1476-1486. doi: 10.1111/jocn.16493. Epub 2022 Aug 24. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2017 |
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| Manometer | Device | Participant will be attached to the manometer within 4 hours after intubation. They will assess 3 times per day during the first 48 hours of intubation in the intensive care unit |
|
| Jul 27, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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