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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03040297 |
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Date of registration:
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27/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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. |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03040297 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Anna K Grigoriadou, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lamia University of Applied Sciences |
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Name:
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Iraklis Tsagaris, MD. PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National and Kapodistrian University of Athens |
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Name:
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Antonia D Koutsoukou, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National and Kapodistrian University of Athens |
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Name:
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Apostolos E Armaganidis |
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Address:
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Telephone:
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Email:
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Affiliation:
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National and Kapodistrian University of Athens |
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Name:
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Konstantinos E Grigoriadis, Pt, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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National and Kapodistrian University of Athens |
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Name:
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Eirini P Grammatopoulou, PT, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Technological Educational Institution of Athens |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
86 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Resp Gas Exchange Disorder Nos
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Intervention(s)
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Device: Tracheal gas insufflation catheter, without gas flow
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Device: Tracheal gas insufflation 11 L/min
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Device: Tracheal gas insufflation 6 L/min
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Primary Outcome(s)
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partial pressure of oxygen (PaO2)
[Time Frame: 60 minutes]
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End respiratory lung impedance differences
[Time Frame: 60 minutes]
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Respiratory Rate
[Time Frame: 60 minutes]
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Secondary Outcome(s)
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Heart Rate
[Time Frame: 60 minutes]
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Oxygen saturation (SaO2)
[Time Frame: 60 minutes]
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Systolic blood pressure
[Time Frame: 60 minutes]
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Diastolic blood pressure
[Time Frame: 60 minutes]
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Secondary ID(s)
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13.4.4.25/05/16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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