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.
Verified date | January 2018 |
Source | Attikon Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Greece | Attikon University Hospital | Athens | Attica |
Lead Sponsor | Collaborator |
---|---|
Attikon Hospital | National and Kapodistrian University of Athens |
Greece,
Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66. Review. — View Citation
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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
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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 |