Clinical Trials Logo
  1. Home
  2. Resp Gas Exchange Disorder Nos
  3. NCT03040297
  4. Details
NCT03040297 Clinical Trial

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

Resp Gas Exchange Disorder Nos Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03040297
Other study ID # 13.4.4.25/05/16
Secondary ID
Status Completed
Phase N/A
First received January 27, 2017
Last updated January 9, 2018
Start date November 2016
Est. completion date May 2017

Study information
Verified date January 2018
Source Attikon Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date May 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 86 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Tracheal gas insufflation 6 L/min
Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
• Tracheal gas insufflation 11 L/min
Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
• Tracheal gas insufflation catheter, without gas flow
Tracheal gas insufflation catheter, without gas flow

Locations
Country Name City State
Greece Attikon University Hospital Athens Attica

Sponsors (2)
Lead Sponsor Collaborator
Attikon Hospital National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (7)

Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66. Review. — View Citation

Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68. Review. — View Citation

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. — View Citation

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. — View Citation

Kacmarek RM. Complications of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):167-76. Review. — View Citation

Knebel AR. When weaning from mechanical ventilation fails. Am J Crit Care. 1992 Nov;1(3):19-29; quiz 30-1. Review. — View Citation

Nahum A. Animal and lung model studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):149-57. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory Rate Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min 60 minutes
Primary partial pressure of oxygen (PaO2) Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min 60 minutes
Primary End respiratory lung impedance differences End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min 60 minutes
Secondary Heart Rate Heart beats per minute at flows: 0, 6, 11, 0 L/min 60 minutes
Secondary Systolic blood pressure Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min 60 minutes
Secondary Diastolic blood pressure Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min 60 minutes
Secondary Oxygen saturation (SaO2) Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min 60 minutes