Attikon University Hospital
Athens, Attica, 12462, Greece
NCT Number: NCT03040297
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.
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Notify Me18 year–86 year
All sexes
Interventional
Not applicable
Athens, Attica, 12462, Greece
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Stable blood gasses (no bigger changes than 15-20% in Oxygen and Carbon dioxide during last 24 hours)
Exclusion criteria
Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
Tracheal gas insufflation catheter, without gas flow
Time frame: 60 minutes
Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min
Time frame: 60 minutes
Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min
Time frame: 60 minutes
End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min
Time frame: 60 minutes
Heart beats per minute at flows: 0, 6, 11, 0 L/min
Time frame: 60 minutes
Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
Time frame: 60 minutes
Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
Time frame: 60 minutes
Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min
Attikon Hospital
Other
Effect of Parallel Oxygen Delivery Through a Tracheal Gas Insufflation (TGI) and a T-piece on Blood Gases and Respiratory Rate in ICU Tracheostomized Patients as an Extra Supporting Method During Weaning From Mechanical Ventilation.
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