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Trial registered on ANZCTR


Registration number
ACTRN12609000606280
Ethics application status
Approved
Date submitted
11/05/2009
Date registered
21/07/2009
Date last updated
21/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non invasive ventilation via helmet in weaning patients with hypoxemic acute respiratory failure
Scientific title
A study on the effects on duration of invasive mechanical ventilation when comparing weaning with early extubation plus non invasive ventilation versus a conventional weaning approach in patients with hypoxemic acute respiratory failure secondary to acute lung injury (ALI) or acute respiratory distress syndrome (ARDS).
Universal Trial Number (UTN)
Trial acronym
NIV and ARF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory failure 4723 0
Condition category
Condition code
Respiratory 237049 237049 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non invasive ventilation (NIV) will be applied through a helmet, which is a transparent latex-free polyvinylchloride hood, secured to the patient by two armpit braces. The ventilator will be set with the same positive end expiratory pressure (PEEP) and inspiratory support applied to the patient before extubation. During the first 24 hours, NIV will be maintained continuously. Thereafter brief discontinuation (less than 5min) will be tolerated for nursing the patients (face, oral hygiene) or to change the non invasive interface. To enhance patient tolerance to NIV, a mild sedation with low doses of remifentanyl (0.025-0.15 microg/kg/min) and/or clonidine (bolus 1 microg/kg/min, than 0.003-0.01 microg/kg/min, max 750-900 microg/die) and/or propofol (10-50 mg/hr) will be allowed. Alternation of interfaces (helmet and mask) will also be accepted during the study period to increase patient tolerance. PEEP will be reduced by 2 cmH2O per hour whenever the PaO2/FiO2 ratio will exceed 225, to a minimum level of 8 cmH2O. No decrease in PEEP will be undertaken if PaO2/FiO2 ratio is below 225. In this case, the attendant physician will re-evaluate the patient after 6 hours. Inspiratory support will be reduced by 2 cmH2O per hour to maintain PaCO2 <= 50 mmHg and pH >= 7.35, to a minimum level of 10 cmH2O. When NIV is set at the minimum levels of PEEP and inspiratory support (8 cmH2O and 10 cmH2O, respectively) and the PaO2/FiO2 is higher than 250, a 30-minute spontaneous breathing trial (SBT) with a Venturi mask 35% will be attempted. The SBT will be interrupted and NIV resumed in case of severe dyspnea, activation of accessory muscles, and paradoxical abdominal motion, respiratory rate (RR) > 30 breaths/min, SpO2 < 90%. At the end of the trial an arterial blood gas analysis will be performed: the patients will be considered successfully weaned off NIV if pH >= 7.35, PaCO2 <= 50 mmHg and PaO2 >= 70 mmHg.
The total duration of NIV treatment will depend on how quick, according to the established algorithm, will be the weaning process and it can vary on a case by case basis.
Intervention code [1] 4494 0
Treatment: Devices
Comparator / control treatment
In the control group, PEEP will be reduced by 2 cmH2O per hour whenever the PaO2/FiO2 ratio will exceed 225, to a minimum level of 8 cmH2O. No decrease in PEEP will be undertaken if PaO2/FiO2 ratio is below 225. In this case, the attendant physician will re-evaluate the patient after 6 hours. Inspiratory support will be reduced by 2 cmH2O per hour to maintain PaCO2 <= 50 mmHg and pH >= 7.35, to a minimum level of 10 cmH2O. When pressure support ventilation (PSV) is set at the minimum levels of PEEP and inspiratory support (8 cmH2O and 10 cmH2O, respectively) and the PaO2/FiO2 is higher than 250, a 30-minute SBT will be attempted. In the control group, the SBT consists in making patient breathing through the circuit of a flow triggered ventilator, set to deliver 5 cmH2O of PEEP and 5 cmH2O of inspiratory support at 35% oxygen. The SBT will be interrupted and increased the total support in case of severe dyspnea, activation of accessory muscles, and paradoxical abdominal motion, RR > 30 breaths/min, SpO2 < 90%. At the end of the trial an arterial blood gas analysis will be performed: the patients will be extubated if pH >= 7.35, PaCO2 <= 50 mmHg and PaO2 >= 70 mmHg.
The total duration of invasive mechanical ventilation treatment will depend on how quick, according to the established algorithm, will be the weaning process and it can vary on a case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 5889 0
Aim of the present study is to investigate whether early extubation followed by NIV application (intervention group) may reduce the duration of invasive mechanical ventilation as compared to conventional weaning in patients with hypoxemic acute respiratory failure (ARF) secondary to ALI/ARDS.
Primary end-point:
Duration (days) of invasive mechanical ventilation.
Method used to assess duration of invasive mechanical ventilation: counting the days starting from the day of inclusion in the weaning protocol till the day of extubation (monitored by clinicians).
Timepoint [1] 5889 0
Daily during intensive care unit (ICU) stay. after the inclusion in the weaning protocol
Secondary outcome [1] 241922 0
Duration (days) of continuous intravenous sedation (monitored by clinicians).
Timepoint [1] 241922 0
Daily during intensive care unit (ICU) stay. after the inclusion in the weaning protocol.
Secondary outcome [2] 241923 0
Side effects / complications of invasive mechanical ventilation: infection, sepsis and ventilator associated pneumonia (VAP), monitored by clinicians.
Timepoint [2] 241923 0
Daily during ICU stay. after the inclusion in the weaning protocol.
Secondary outcome [3] 244780 0
ICU mortality, monitored by clinicians.
Timepoint [3] 244780 0
Daily during ICU stay. after the inclusion in the weaning protocol.
Secondary outcome [4] 244781 0
Number of tracheotomy, monitored by clinicians.
Timepoint [4] 244781 0
Daily during ICU stay. after the inclusion in the weaning protocol.
Secondary outcome [5] 244782 0
Hospital mortality, monitored by clinicians.
Timepoint [5] 244782 0
Daily. after discharge from the ICU.

Eligibility
Key inclusion criteria
Invasive mechanical ventilation duration > 48 hours; PaO2/FiO2 ranging between 200 and 300 with a positive end-expiratory pressure PEEP < = 12 cmH2O and a FiO2 <= 0.6; Pressure Support Ventilation (PSV) with a total applied pressure (i.e. PEEP + inspiratory support) <= 25 cmH2O; PaCO2 <= 50 mmHg; pH >= 7.35; Respiratory rate (RR) <= 30/min; Core body temperature <= 38.5 (degrees celsius); Glasgow Coma Scale (GCS) >= 10; Presence of clearly audible cough during suctioning; Tracheal suctioning<= 2/hr
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe hemodynamic instability as assessed: a) systolic arterial pressure < 90 mmHg, despite adequate filling, b) need for continuous infusion of epinephrine, norepinephrine or vasopressine, c) need for dopamine or dobutamine > 5microg/Kg/min
Life-threatening arrhythmias or ECG signs of ischemia; Severe sepsis or septic shock;
ARF secondary to congestive heart failure, neurological disorders, status asmaticus, chronic obstructive pulmonary disease; Tracheotomy; Copious secretions or uncontrolled vomiting; Spinal cord injury or neuro-muscular disorder; Presence of 2 or more criteria of organ failure; Body mass index >= 30; Obstructive sleep apnea syndrome

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
Use of random number table supports to create a randomised sequence for treatment assignment
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 1752 0
Italy
State/province [1] 1752 0

Funding & Sponsors
Funding source category [1] 237318 0
University
Name [1] 237318 0
University of Eastern Piedmont
Country [1] 237318 0
Italy
Primary sponsor type
Individual
Name
Navalesi Paolo
Address
University od Eastern Piedmont
Department of Clinical and Experimental Medicine and Department of Anesthesia and Intensive Care
Corso Mazzini 18,
28100 Novara
Country
Italy
Secondary sponsor category [1] 236802 0
None
Name [1] 236802 0
Address [1] 236802 0
Country [1] 236802 0
Other collaborator category [1] 665 0
Individual
Name [1] 665 0
Antonelli Massimo
Address [1] 665 0
Policlinico A. Gemelli, University hospital, Department of Anesthesia and Intensive care
Largo A. Gemelli, 8
00168 Roma
Country [1] 665 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6969 0
Comitato Etico Interaziendale Novara
Ethics committee address [1] 6969 0
Corso Mazzini n. 18
28100 Novara
Ethics committee country [1] 6969 0
Italy
Date submitted for ethics approval [1] 6969 0
Approval date [1] 6969 0
18/04/2008
Ethics approval number [1] 6969 0

Summary
Brief summary
Although mechanical ventilation is a life-saving treatment, endotracheal intubation is the most important risk factor for nosocomial pneumonia and increases patients’ discomfort and need for sedatives, which increases in turn the time spent on mechanical ventilation and intensive care unit length of stay.
Non-invasive ventilation (NIV) may be used (1) to prevent the occurrence of impending (but not established) acute or post-extubation failure, (2) at an early stage, when respiratory failure is already established, to avert the need for endotracheal intubation, and (3) as an alternative to invasive ventilation at a more advanced stage of acute respiratory failure or to facilitate the process of weaning from mechanical ventilation.
No controlled randomized study, however has so far investigated the potential role of NIV in the weaning process of patients with acute lung injury (ALI).
The aim of the present study is to investigate whether early extubation followed by NIV application (intervention group) may reduce the duration of invasive mechanical ventilation as compared to conventional weaning in patients with hypoxemic acute respiratory failure secondary to ALI or acute respiratory distress syndrome(ARDS).
We will performed a prospective randomized multicentre controlled trial. One-hundred-ten patients with ALI will be randomize to receive weaning via early extubation followed by NIV application (intervention group) or via endotracheal tube in place (control group).
We expect to find that NIV application by well-experienced centres, will increased patient ventilator free days and decrease complications as compared with the traditional weaning process via endotracheal tube.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29573 0
Address 29573 0
Country 29573 0
Phone 29573 0
Fax 29573 0
Email 29573 0
Contact person for public queries
Name 12820 0
Paolo Navalesi
Address 12820 0
Corso Mazzini 18,
28100 Novara
Country 12820 0
Italy
Phone 12820 0
+ 39 0321 3733406
Fax 12820 0
Email 12820 0
paolo.navalesi@fastwebnet.it
Contact person for scientific queries
Name 3748 0
Paolo Navalesi
Address 3748 0
Corso Mazzini 18,
28100 Novara
Country 3748 0
Italy
Phone 3748 0
+ 39 0321 3733406
Fax 3748 0
Email 3748 0
paolo.navalesi@fastwebnet.it

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Results publications and other study-related documents

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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4254Study results articleYes Vaschetto R, Turucz E, Dellapiazza F, Guido S, Col... [More Details]

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