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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

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ClinicalTrials.gov Identifier: NCT03040297
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Konstantinos Grigoriadis, Attikon Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Resp Gas Exchange Disorder Nos Device: Tracheal gas insufflation 6 L/min Device: Tracheal gas insufflation 11 L/min Device: Tracheal gas insufflation catheter, without gas flow Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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.
Study Start Date : November 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TGI 6 L/min
Tracheal gas insufflation 6 L/min
 Device: Tracheal gas insufflation 6 L/min
Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
Active Comparator: TGI 11 L/min
Tracheal gas insufflation 11 L/min
 Device: Tracheal gas insufflation 11 L/min
Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
Active Comparator: TGI 0 L/min
Tracheal gas insufflation catheter, without gas flow
 Device: Tracheal gas insufflation catheter, without gas flow
Tracheal gas insufflation catheter, without gas flow


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040297


Locations
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Greece
Attikon University Hospital
Athens, Attica, Greece, 12462
Sponsors and Collaborators
Attikon Hospital
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Konstantinos E Grigoriadis, Pt, MSc National and Kapodistrian University of Athens
Study Chair: Iraklis Tsagaris, MD. PhD National and Kapodistrian University of Athens
Study Chair: Antonia D Koutsoukou, MD, PhD National and Kapodistrian University of Athens
Study Chair: Eirini P Grammatopoulou, PT, PhD Technological Educational Institution of Athens
Study Chair: Anna K Grigoriadou, PT Lamia University of Applied Sciences
Study Director: Apostolos E Armaganidis National and Kapodistrian University of Athens
More Information
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Publications:

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Responsible Party: Konstantinos Grigoriadis, Physical Therapist, Attikon Hospital
ClinicalTrials.gov Identifier: NCT03040297    
Other Study ID Numbers: 13.4.4.25/05/16
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Konstantinos Grigoriadis, Attikon Hospital:
Weaning from mechanical ventilation
tracheostomized patients
Tracheal gas insufflation