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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

Tracking Information
First Submitted Date  ICMJE January 27, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date January 10, 2018
Study Start Date  ICMJE November 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • Respiratory Rate [ Time Frame: 60 minutes ]
    Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min
  • partial pressure of oxygen (PaO2) [ Time Frame: 60 minutes ]
    Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min
  • End respiratory lung impedance differences [ Time Frame: 60 minutes ]
    End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • Heart Rate [ Time Frame: 60 minutes ]
    Heart beats per minute at flows: 0, 6, 11, 0 L/min
  • Systolic blood pressure [ Time Frame: 60 minutes ]
    Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
  • Diastolic blood pressure [ Time Frame: 60 minutes ]
    Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
  • Oxygen saturation (SaO2) [ Time Frame: 60 minutes ]
    Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Resp Gas Exchange Disorder Nos
Intervention  ICMJE
  • Device: Tracheal gas insufflation 6 L/min
    Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
  • Device: Tracheal gas insufflation 11 L/min
    Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
  • Device: Tracheal gas insufflation catheter, without gas flow
    Tracheal gas insufflation catheter, without gas flow
Study Arms  ICMJE
  • Active Comparator: TGI 6 L/min
    Tracheal gas insufflation 6 L/min
    Intervention: Device: Tracheal gas insufflation 6 L/min
  • Active Comparator: TGI 11 L/min
    Tracheal gas insufflation 11 L/min
    Intervention: Device: Tracheal gas insufflation 11 L/min
  • Active Comparator: TGI 0 L/min
    Tracheal gas insufflation catheter, without gas flow
    Intervention: Device: Tracheal gas insufflation catheter, without gas flow
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
11
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 86 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040297
Other Study ID Numbers  ICMJE 13.4.4.25/05/16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Konstantinos Grigoriadis, Attikon Hospital
Study Sponsor  ICMJE Attikon Hospital
Collaborators  ICMJE National and Kapodistrian University of Athens
Investigators  ICMJE
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
PRS Account Attikon Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP