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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Before gasses supply via TGI During 6L/min During 11L/min 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.

Official Title
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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.

Conditions
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Resp Gas Exchange Disorder Nos

Intervention / Treatment
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* Device: Tracheal gas insufflation 6 L/min
* Device: Tracheal gas insufflation 11 L/min
* Device: Tracheal gas insufflation catheter, without gas flow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tracheostomized haemodynamically stable patients, without the need of vasopressors or inotrope medications, without symptoms of pulmonary edema, or interstitial lung diseases. Stable blood gasses (no bigger changes than 15-20% in Oxygen and Carbon dioxide during last 24 hours) Exclusion Criteria: Peripheral body temperature < 38 C, White blood cells (WBCs) < 15 x 109/L Respiratory rate >35 Paradoxical breathing Abdominal muscle recruitment Dyspnoea, SaO2 < 94, without evidence of angina, cyanosis or arrhythmia. Chest circumferences no bigger than 110 cm (for the larger belt of impedance tomograph)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TGI 6 L/min<br>Tracheal gas insufflation 6 L/min | Device: Tracheal gas insufflation 6 L/min<br>* Endotracheal flow (6 L/min) of respiratory gases with standard FiO2<br>|
| Active Comparator: TGI 11 L/min<br>Tracheal gas insufflation 11 L/min | Device: Tracheal gas insufflation 11 L/min<br>* Endotracheal flow (11 L/min) of respiratory gases with standard FiO2<br>|
| Active Comparator: TGI 0 L/min<br>Tracheal gas insufflation catheter, without gas flow | Device: Tracheal gas insufflation catheter, without gas flow<br>* Tracheal gas insufflation catheter, without gas flow<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weaning from mechanical ventilation, tracheostomized patients, Tracheal gas insufflation