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

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

Tracking Information

• First Submitted Date: January 27, 2017
• First Posted Date: February 2, 2017
• Last Update Posted Date: January 10, 2018
• Study Start Date: November 2016
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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.
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Resp Gas Exchange Disorder Nos

Intervention

• 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

• 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 *

• Knebel AR. When weaning from mechanical ventilation fails. Am J Crit Care. 1992 Nov;1(3):19-29; quiz 30-1. Review.
• Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68. Review.
• Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66. Review.
• 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. Review.
• Nahum A. Animal and lung model studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):149-57. Review.
• Kacmarek RM. Complications of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):167-76. Review.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2017): 11
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2017
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 86 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Greece

Administrative Information

• NCT Number: NCT03040297
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Konstantinos Grigoriadis, Attikon Hospital
• Study Sponsor: Attikon Hospital
• Collaborators: National and Kapodistrian University of Athens

Investigators

• 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