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.

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.

Study Overview

• Status: Completed
• Conditions: Resp Gas Exchange Disorder Nos
• Intervention / Treatment: Device: Tracheal gas insufflation 6 L/min; Device: Tracheal gas insufflation 11 L/min; Device: Tracheal gas insufflation catheter, without gas flow

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
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 12462
      • Attikon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Rate	Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min	60 minutes
partial pressure of oxygen (PaO2)	Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min	60 minutes
End respiratory lung impedance differences	End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart beats per minute at flows: 0, 6, 11, 0 L/min	60 minutes
Systolic blood pressure	Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min	60 minutes
Diastolic blood pressure	Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min	60 minutes
Oxygen saturation (SaO2)	Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min	60 minutes

Collaborators and Investigators

• 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

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Weaning from mechanical ventilation; tracheostomized patients; Tracheal gas insufflation
• Other Study ID Numbers: 13.4.4.25/05/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No