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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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The study investigates if there are benefits (better oxygenation, minimized work of breath) from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide respiratory support in tracheostomized patients and avoid mechanical ventilation.
The tracheal insufflation (TGI) of respiratory gasses near to carina is a technique who designed for the removement of exhaled carbon dioxide from the dead space of the lung. In order to investigate the utility of this technique on weaning of mechanical ventilation 11 tracheostomized patients on T-piece were recruited, with stable blood gasses more than 24 hours.
A TGI catheter enters the trachea through a new opened hole on the top of T-piece and then passes through the tracheostomy tube to inside of the trachea and then stops one centimeter before the carina. Patients received two parallel administered respiratory gases with the same fraction of inspired oxygen (FiO2), through a T-piece and an endotracheal catheter, with flows 6 Liters Per Minute (L/min) and 11 L/min, while continuously monitored by impedance tomography device (ΕΙΤ). ΕΙΤ is a noninvasive imaging technique for monitoring in real time the lung volumes and the regional lung ventilation without ionizing radiation.
The basic hypothesis of the study is if there are benefits (better oxygenation, minimized work of breath) from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide respiratory support in tracheostomized patients and avoid mechanical ventilation.
The randomization of the study was achieved using sealed envelopes method and associated with the flow to be first (6L/min or 11L/min) via Tracheal Gas Insufflation Catheter (6 envelopes with the inscription 6 L/min on the inner side and 6 envelopes with the inscription 6 L/min on the inner side 11 L/min)
Τhe investigators tested the differences on partial pressure of oxygen (PaO2), respiratory rate and end expiratory impedance:
Additionally the following were monitored:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TGI 6 L/min | Active Comparator | Tracheal gas insufflation 6 L/min |
|
| TGI 11 L/min | Active Comparator | Tracheal gas insufflation 11 L/min |
|
| TGI 0 L/min | Active Comparator | Tracheal gas insufflation catheter, without gas flow |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tracheal gas insufflation 6 L/min | Device | Endotracheal flow (6 L/min) of respiratory gases with standard FiO2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate | Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min | 60 minutes |
| partial pressure of oxygen (PaO2) | Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min | 60 minutes |
| End respiratory lung impedance differences | End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart beats per minute at flows: 0, 6, 11, 0 L/min | 60 minutes |
| Systolic blood pressure | Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min |
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Inclusion Criteria:
Stable blood gasses (no bigger changes than 15-20% in Oxygen and Carbon dioxide during last 24 hours)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos E Grigoriadis, Pt, MSc | National and Kapodistrian University of Athens | Principal Investigator |
| Iraklis Tsagaris, MD. PhD | National and Kapodistrian University of Athens | Study Chair |
| Antonia D Koutsoukou, MD, PhD | National and Kapodistrian University of Athens | Study Chair |
| Eirini P Grammatopoulou, PT, PhD | Technological Educational Institution of Athens | Study Chair |
| Anna K Grigoriadou, PT | Lamia University of Applied Sciences | Study Chair |
| Apostolos E Armaganidis | National and Kapodistrian University of Athens | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attikon University Hospital | Athens | Attica | 12462 | Greece |
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| Tracheal gas insufflation 11 L/min | Device | Endotracheal flow (11 L/min) of respiratory gases with standard FiO2 |
|
| Tracheal gas insufflation catheter, without gas flow | Device | Tracheal gas insufflation catheter, without gas flow |
|
| 60 minutes |
| Diastolic blood pressure | Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min | 60 minutes |
| Oxygen saturation (SaO2) | Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min | 60 minutes |
| 11175244 | Background | Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66. |
| 12526235 | Background | Hoffman LA, Tasota FJ, Delgado E, Zullo TG, Pinsky MR. Effect of tracheal gas insufflation during weaning from prolonged mechanical ventilation: a preliminary study. Am J Crit Care. 2003 Jan;12(1):31-9. |
| 11175241 | Background | Hess DR, Gillette MA. Tracheal gas insufflation and related techniques to introduce gas flow into the trachea. Respir Care. 2001 Feb;46(2):119-29. |
| 11175243 | Background | Nahum A. Animal and lung model studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):149-57. |
| 11175245 | Background | Kacmarek RM. Complications of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):167-76. |