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
NCT ID: NCT03040297
Last Updated: 2018-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2016-11-30
2017-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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TGI 6 L/min
Tracheal gas insufflation 6 L/min
Tracheal gas insufflation 6 L/min
Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
TGI 11 L/min
Tracheal gas insufflation 11 L/min
Tracheal gas insufflation 11 L/min
Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
TGI 0 L/min
Tracheal gas insufflation catheter, without gas flow
Tracheal gas insufflation catheter, without gas flow
Tracheal gas insufflation catheter, without gas flow
Interventions
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Tracheal gas insufflation 6 L/min
Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
Tracheal gas insufflation 11 L/min
Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
Tracheal gas insufflation catheter, without gas flow
Tracheal gas insufflation catheter, without gas flow
Eligibility Criteria
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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
* 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)
18 Years
86 Years
ALL
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Attikon Hospital
OTHER
Responsible Party
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Konstantinos Grigoriadis
Physical Therapist
Principal Investigators
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Konstantinos E Grigoriadis, Pt, MSc
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrian University of Athens
Iraklis Tsagaris, MD. PhD
Role: STUDY_CHAIR
National and Kapodistrian University of Athens
Antonia D Koutsoukou, MD, PhD
Role: STUDY_CHAIR
National and Kapodistrian University of Athens
Eirini P Grammatopoulou, PT, PhD
Role: STUDY_CHAIR
Technological Educational Institution of Athens
Anna K Grigoriadou, PT
Role: STUDY_CHAIR
Lamia University of Applied Sciences
Apostolos E Armaganidis
Role: STUDY_DIRECTOR
National and Kapodistrian University of Athens
Locations
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Attikon University Hospital
Athens, Attica, Greece
Countries
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References
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Knebel AR. When weaning from mechanical ventilation fails. Am J Crit Care. 1992 Nov;1(3):19-29; quiz 30-1.
Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66.
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.
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.
Nahum A. Animal and lung model studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):149-57.
Kacmarek RM. Complications of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):167-76.
Other Identifiers
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13.4.4.25/05/16
Identifier Type: -
Identifier Source: org_study_id
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