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Completed

NCT Number: NCT03040297

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

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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Key information

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Attikon University Hospital

Athens, Attica, 12462, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tracheal gas insufflation 6 L/min

Device

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

Tracheal gas insufflation 11 L/min

Device

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

Tracheal gas insufflation catheter, without gas flow

Device

Tracheal gas insufflation catheter, without gas flow

Primary outcomes

  1. Respiratory Rate

    Time frame: 60 minutes

    Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min

  2. partial pressure of oxygen (PaO2)

    Time frame: 60 minutes

    Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min

  3. End respiratory lung impedance differences

    Time frame: 60 minutes

    End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min

Secondary outcomes

  1. Heart Rate

    Time frame: 60 minutes

    Heart beats per minute at flows: 0, 6, 11, 0 L/min

  2. Systolic blood pressure

    Time frame: 60 minutes

    Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min

  3. Diastolic blood pressure

    Time frame: 60 minutes

    Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min

  4. Oxygen saturation (SaO2)

    Time frame: 60 minutes

    Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.