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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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03040297
Enrollment
11
Registered
2017-02-02
Start date
2016-11-30
Completion date
2017-05-31
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resp Gas Exchange Disorder Nos

Keywords

Weaning from mechanical ventilation, tracheostomized patients, Tracheal gas insufflation

Brief 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.

Interventions

DEVICETracheal gas insufflation 6 L/min

Endotracheal flow (6 L/min) of respiratory gases with standard FiO2

DEVICETracheal gas insufflation 11 L/min

Endotracheal flow (11 L/min) of respiratory gases with standard FiO2

DEVICETracheal gas insufflation catheter, without gas flow

Tracheal gas insufflation catheter, without gas flow

Sponsors

National and Kapodistrian University of Athens
CollaboratorOTHER
Attikon Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 86 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Rate60 minutesRespiratory cycles per minute at flows: 0, 6, 11, 0 L/min
partial pressure of oxygen (PaO2)60 minutesArterial blood oxygen tension at flows: 0, 6, 11,0 L/min
End respiratory lung impedance differences60 minutesEnd respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min

Secondary

MeasureTime frameDescription
Heart Rate60 minutesHeart beats per minute at flows: 0, 6, 11, 0 L/min
Oxygen saturation (SaO2)60 minutesOxygen saturation (%) at flows: 0, 6, 11, 0 L/min
Systolic blood pressure60 minutesSystolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
Diastolic blood pressure60 minutesDiastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026