Resp Gas Exchange Disorder NosNCT03040297
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
A study testing Tracheal gas insufflation 6 L/min, Tracheal gas insufflation 11 L/min and Tracheal gas insufflation catheter, without gas flow in people with Resp Gas Exchange Disorder Nos, run by Attikon Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Resp Gas Exchange Disorder Nos
- What is being tested?
- Tracheal gas insufflation 6 L/min, Tracheal gas insufflation 11 L/min and Tracheal gas insufflation catheter, without gas flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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:
- Before gasses supply via TGI
- During 6L/min
- During 11L/min
- 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.
- Conditions
- Resp Gas Exchange Disorder Nos
- Being tested
- Tracheal gas insufflation 6 L/min, Tracheal gas insufflation 11 L/min, Tracheal gas insufflation catheter, without gas flow
- Keywords
- Weaning from mechanical ventilation, tracheostomized patients, Tracheal gas insufflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal gas insufflation 6 L/minDevice
Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
Tracheal gas insufflation 11 L/minDevice
Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
Tracheal gas insufflation catheter, without gas flowDevice
Tracheal gas insufflation catheter, without gas flow
| Study group | Role | What they receive |
|---|---|---|
| TGI 6 L/min | Active comparator | Tracheal gas insufflation 6 L/min Receives: Device: Tracheal gas insufflation 6 L/min |
| TGI 11 L/min | Active comparator | Tracheal gas insufflation 11 L/min Receives: Device: Tracheal gas insufflation 11 L/min |
| TGI 0 L/min | Active comparator | Tracheal gas insufflation catheter, without gas flow Receives: Device: Tracheal gas insufflation catheter, without gas flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate
Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min
Measured: 60 minutes
partial pressure of oxygen (PaO2)
Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min
Measured: 60 minutes
End respiratory lung impedance differences
End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min
Measured: 60 minutes
Secondary outcomes (4)
Heart Rate
Heart beats per minute at flows: 0, 6, 11, 0 L/min
Measured: 60 minutes
Systolic blood pressure
Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
Measured: 60 minutes
Diastolic blood pressure
Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
Measured: 60 minutes
Oxygen saturation (SaO2)
Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startNov 2016
- Primary completionJan 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Resp Gas Exchange Disorder NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Konstantinos Grigoriadis, Attikon Hospital
- Investigators
- Konstantinos E Grigoriadis, Pt, MSc, Principal investigator, National and Kapodistrian University of AthensIraklis Tsagaris, MD. PhD, Study chair, National and Kapodistrian University of AthensAntonia D Koutsoukou, MD, PhD, Study chair, National and Kapodistrian University of AthensEirini P Grammatopoulou, PT, PhD, Study chair, Technological Educational Institution of AthensAnna K Grigoriadou, PT, Study chair, Lamia University of Applied SciencesApostolos E Armaganidis, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040297
- Sponsor's protocol ID
- 13.4.4.25/05/16
- Status last verified
- Jan 2018
- First submitted
- 27 Jan 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knebel AR. When weaning from mechanical ventilation fails. Am J Crit Care. 1992 Nov;1(3):19-29; quiz 30-1.
PubMed 1307903Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
PubMed 20667153Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66.
PubMed 11175244Hoffman 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.
PubMed 12526235Hess DR, Gillette MA. Tracheal gas insufflation and related techniques to introduce gas flow into the trachea. Respir Care. 2001 Feb;46(2):119-29.
PubMed 11175241Nahum A. Animal and lung model studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):149-57.
PubMed 11175243Kacmarek RM. Complications of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):167-76.
PubMed 11175245
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03040297
- Acronym / sponsor ID
- 13.4.4.25/05/16
- Conditions
- Resp Gas Exchange Disorder Nos
- Keywords
- Weaning from mechanical ventilation, tracheostomized patients, Tracheal gas insufflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- Nov 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Before gasses supply via TGI
- During 6L/min
- During 11L/min
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TGI 6 L/min | Active comparator | Device: Tracheal gas insufflation 6 L/minTracheal gas insufflation 6 L/min |
| TGI 11 L/min | Active comparator | Device: Tracheal gas insufflation 11 L/minTracheal gas insufflation 11 L/min |
| TGI 0 L/min | Active comparator | Device: Tracheal gas insufflation catheter, without gas flowTracheal gas insufflation catheter, without gas flow |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheal gas insufflation 6 L/minEndotracheal flow (6 L/min) of respiratory gases with standard FiO2 | Device | TGI 6 L/min |
| Tracheal gas insufflation 11 L/minEndotracheal flow (11 L/min) of respiratory gases with standard FiO2 | Device | TGI 11 L/min |
| Tracheal gas insufflation catheter, without gas flowTracheal gas insufflation catheter, without gas flow | Device | TGI 0 L/min |
Primary outcome
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
4 secondary outcomes
Heart Rate
Time frame: 60 minutes
Systolic blood pressure
Time frame: 60 minutes
Diastolic blood pressure
Time frame: 60 minutes
Oxygen saturation (SaO2)
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Background: PubMed 1307903Knebel AR. When weaning from mechanical ventilation fails. Am J Crit Care. 1992 Nov;1(3):19-29; quiz 30-1.
- Background: PubMed 20667153Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
- Background: PubMed 11175244Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66.
- Background: PubMed 12526235Hoffman 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.
- Background: PubMed 11175241Hess DR, Gillette MA. Tracheal gas insufflation and related techniques to introduce gas flow into the trachea. Respir Care. 2001 Feb;46(2):119-29.
- Background: PubMed 11175243Nahum A. Animal and lung model studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):149-57.
- Background: PubMed 11175245Kacmarek RM. Complications of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):167-76.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos E Grigoriadis, Pt, MSc principal investigator
National and Kapodistrian University of Athens
Iraklis Tsagaris, MD. PhD study chair
National and Kapodistrian University of Athens
Antonia D Koutsoukou, MD, PhD study chair
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal gas insufflation 6 L/min, Tracheal gas insufflation 11 L/min and Tracheal gas insufflation catheter, without gas flow in people with Resp Gas Exchange Disorder Nos, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate (time frame: 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040297, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.