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Trial registered on ANZCTR


Registration number
ACTRN12616001727437
Ethics application status
Approved
Date submitted
8/11/2016
Date registered
16/12/2016
Date last updated
9/11/2018
Date data sharing statement initially provided
9/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of noninvasive ventilation (NIV) and high flow nasal therapy (HFNT) after early extubation in chest trauma patients
Scientific title
Effect of sequential use of noninvasive ventilation (NIV) and high flow nasal therapy (HFNT) after early extubation on re-intubation rate in chest trauma patients recovering from hypoxemic acute respiratory failure: a single-center feasibility study
Secondary ID [1] 290484 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chest trauma 300863 0
respiratory failure 300864 0
Condition category
Condition code
Injuries and Accidents 300684 300684 0 0
Other injuries and accidents
Anaesthesiology 300685 300685 0 0
Other anaesthesiology
Respiratory 300787 300787 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sequential use of Non-invasive ventilation (NIV) and High flow nasal therapy.

After inclusion, subjects will be treated successively first with a 2-h session of NIV then with a 1-h session of HFNT. Sequential application of these 2 treatments will be repeated to deliver 16h of NIV and 8 h of HFNT per day.
The intervention will be administered by treating doctors.
The intervention will be modulated as following: PEEP and Pressure support (PS) will be decreased by 2 cmH2O each if after 2 h on NIV when PaO2/FiO2 will exceeded 250mmHg till a minimum of 5 and 8 cmH2O. At this time patient will be switched to HFNT only. HFNT will be interrupted if at the end of the all the following occurred: pH >7.35, PaCO2 < 45mmHg and PaO2 > 70 mmHg, RR < 30 breaths/min, absence of dyspnoea, respiratory accessory muscles recruitment, and paradoxical abdominal motion during 30-min spontaneous breathing trial (SBT) with oxygen supplementation through a Venturi mask at a FiO2 of 0.35.
The HFNT device (Optiflow, Fisher & Paykel Healthcare, Auckland, New Zealand) includes a venturi air-oxygen blender, which allows the accurate adjustment of FiO2 between 0.30 and 1.0 and delivery of gas flow up to 60 L/min through a heated humidifier (MR850, Fisher & Paykel Healthcare). The gas mixture will be routed through a circuit to the subject at a temperature of 37 degree Celtius and an absolute humidity of 44 mg/L via large-bore bi-nasal prongs. HFNC was initially administered at a gas flow of 60 L/min and a FIO2 of 1.0. FIO2 will be adjusted to maintain a SpO2 > 92%. NIV will be delivered to the subject in a semi recumbent position with a full-face mask (Fisher & Paykel Healthcare) connected to an ICU ventilator with a dedicated NIV mode (Evita 2 Dura-Drager Lubeck- Germany) equipped with a heated humidifier (Kendall Aerodyne Ultratherm). Full-face and oronasal masks will be utilized in rotation, to improve patient tolerance to NIV, as indicated. Subjects will be ventilated by NIV at the same support used before extubation. After that pressure support level will be targeted to an expired tidal volume of 7-8 mL/kg, PaCO2 < 45 mmHg, a pH >7.35 and RR< 30/breaths/min. PEEP will be adjusted to maintain PaO2/FiO2 ratio > 225. In the case PaO2/FiO2 will be less than 200 mmHg during NIV, PEEP will be increased to reach the target of 225 mmHg and left at that level for next three NIV rounds before reattempting its reduction. In the case PaO2/FiO2 will be less than 225 mmHg and at least 200 mmHg during HFNT NIV will be reassumed for 2 hours before restarting HFNT.

Duration of the intervention: PEEP and PS will be decreased by 2 cmH2O each if after 2 hours on NIV when PaO2/FiO2 will exceeded 250mmHg till a minimum of 5 and 8 cmH2O. At this time patient will be switched to HFNT only. HFNT will be interrupted if at the end of the all the following parameters will occur: pH >7.35, PaCO2 < 45mmHg and PaO2 > 70 mmHg, RR < 30 breaths/min, absence of dyspnoea, respiratory accessory muscles recruitment, and paradoxical abdominal motion during 30-min spontaneous breathing trial (SBT) with oxygen supplementation through a Venturi mask at a FiO2 of 0.35.
Intervention code [1] 296342 0
Treatment: Other
Intervention code [2] 296412 0
Treatment: Devices
Comparator / control treatment
No control treatment. Is a single-arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300105 0
Re-intubation rate
Predefined criteria for re-intubation will be:
Any of the following:
1) cardiac or respiratory arrest;
2) inability to protect the airway;
3) coma or psychomotor agitation with RASS >3 not controlled by continuous i.v. sedative infusion, as previously described
4) unmanageable secretions or uncontrolled vomiting;
5) life-threatening arrhythmias or electrocardiographic signs of ischemia; hemodynamic instability, as already described;
6) intolerance to all interfaces;

OR

Two of the following:
1) severe dyspnea
2) PaO2/FiO2 < 200 mmHg
3) respiratory acidosis (pH <7.35 and PaCO2 >50 mmHg)
4) an increase in respiratory rate 20% from the time of extubation or a breathing frequency > 35 breaths/min
5) clinical signs of “incipient” respiratory muscle fatigue (use of accessory muscles, inward movements of the abdomen during inspiration)
6) inability to remove secretions (Airway Care Score)

The described conditions will be evaluated by treating physicians
Timepoint [1] 300105 0
At any time during ICU stay (from admission into ICU until ICU discharge)
Secondary outcome [1] 329065 0
PaO2/FiO2 ratio assessed by arterial blood test
Timepoint [1] 329065 0
One hour after the initiation of NIV and HFNT. Then, two assessment daily or whenever required by physician in charge from ICU admission until ICU discharge
Secondary outcome [2] 329342 0
Intolerance to the devices evaluated by the attending physician
Timepoint [2] 329342 0
At the end of each NIV or HFNT session
Secondary outcome [3] 329343 0
Side effects of the interventions (e.g. skin damage) assessed by treating physicians
Timepoint [3] 329343 0
At the end of each NIV or HFNT session

Eligibility
Key inclusion criteria
All of the following:

1) age equal or higher than 18 years;
2) Invasive Mechanical Ventilation (iMV) for at least 24h;
3) pressure support ventilation (PSV) with a total applied pressure, i.e. positive end-expiratory pressure (PEEP) inspiratory support, < 20 cmH2O and a PEEP level between 8 and 10 cmH2O;
4) PaO2/FiO2 between 200 and 300 mmHg
5) PaCO2 < 45mmHg and pH > 7.35;
6) respiratory rate (RR) < 30/min;
7) core temperature < 38.5 degree Celtius; (8)
8) Glasgow coma scale (GCS) equal or higher than 11;
9) Richmond Agitation Sedation Score < 3;
10) cough on suctioning and need for tracheobronchial suctioning less than 2 per hour.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
One of the following:

1) hemodynamic instability i.e. systolic arterial pressure < 90 mmHg despite fluid repletion;
2) use of vasoactive agents, i.e. vasopressin, epinephrine and norepinephrine at any dosage, and dopamine or dobutamine > 5mcg/kg/min;
3) life-threatening arrhythmias or electrocardiographic signs of ischemia;
4) sepsis or septic shock;
5) ARF secondary to neurological disorders, status asthmaticus, COPD, cardiogenic pulmonary oedema;
6) presence of tracheotomy;
7) uncontrolled vomiting;
8) uncontrolled agitation RASS >3 5;
9) two or more organ failures;
10) body mass index > 30;
11) documented history or suspicion of obstructive sleep apnoea;
12) unstable flail chest
13) recent upper airway or esophageal surgery
14) ongoing pregnancy
15) inclusion in other research protocols.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/01/2017
Actual
24/11/2017
Date of last participant enrolment
Anticipated
22/04/2019
Actual
Date of last data collection
Anticipated
2/09/2019
Actual
Sample size
Target
30
Accrual to date
16
Final
Recruitment outside Australia
Country [1] 8377 0
Italy
State/province [1] 8377 0
Sicily

Funding & Sponsors
Funding source category [1] 294901 0
University
Name [1] 294901 0
University of Palermo. Policlinico P. Giaccone
Country [1] 294901 0
Italy
Funding source category [2] 294902 0
Hospital
Name [2] 294902 0
ARNAS Civico Di Cristina Benfratelli
Country [2] 294902 0
Italy
Primary sponsor type
University
Name
University of Palermo. Pocliclinico P. Giaccone
Address
Via del vespro 129, 90127 Palermo, Italy
Country
Italy
Secondary sponsor category [1] 293739 0
Hospital
Name [1] 293739 0
ARNAS Civico Di Cristina Benfratelli
Address [1] 293739 0
Piazza Nicola Leotta 4 - 90127 Palermo
Country [1] 293739 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296278 0
Comitato Etico Palermo 1
Ethics committee address [1] 296278 0
Ethics committee country [1] 296278 0
Italy
Date submitted for ethics approval [1] 296278 0
12/09/2016
Approval date [1] 296278 0
19/10/2016
Ethics approval number [1] 296278 0
9/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70246 0
Dr Andrea Cortegiani
Address 70246 0
University Hospital Policlinico P. Giaccone. University of Palermo. Via del vespro 129, 90127 Palermo
Country 70246 0
Italy
Phone 70246 0
+390916552730
Fax 70246 0
Email 70246 0
cortegiania@gmail.com
Contact person for public queries
Name 70247 0
Andrea Cracchiolo
Address 70247 0
ARNAS Civico Di Cristina Benfratelli. Piazza Leotta 4 - 90127, Palermo, Italy
Country 70247 0
Italy
Phone 70247 0
+393339230962
Fax 70247 0
Email 70247 0
ancracchiolo@hotmail.com
Contact person for scientific queries
Name 70248 0
Andrea Cortegiani
Address 70248 0
University Hospital Policlinico P. Giaccone. University of Palertmo. Via del vespro 129, 90127 Palermo, Italy
Country 70248 0
Italy
Phone 70248 0
+390916552730
Fax 70248 0
Email 70248 0
cortegiania@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Discussing with University Department about this possibility


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.