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
Condition: Resp Gas Exchange Disorder Nos
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. Before gasses supply via TGI

        2. During 6L/min

        3. During 11L/min

        4. And finally with no gasses supply via TGI

      Additionally the following were monitored:

        -  Heart rate

        -  Systolic and diastolic blood pressure

        -  Oxygen saturation as disturbing factors and,

        -  potential of hydrogen (pH)

        -  PaCO2

        -  hydrogen carbonate (-HCO3) for the monitoring of the acid-base balance of the patient
           during procedure.
    

Intervention name(s): Tracheal gas insufflation 6 L/min; Tracheal gas insufflation 11 L/min; Tracheal gas insufflation catheter, without gas flow
Intervention type(s): Device; Device; Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Weaning from mechanical ventilation; tracheostomized patients; Tracheal gas insufflation