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Trial registered on ANZCTR


Registration number
ACTRN12612000372886
Ethics application status
Approved
Date submitted
11/03/2012
Date registered
2/04/2012
Date last updated
8/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a weaning protocol facilitate liberation from mechanical ventilation in tracheostomized brain-injured patients?
Scientific title
Is a systematic approach to wean superior to the physician's judgment in preventing weaning failure occurring within 48 hrs, in neurological patients undergoing mechanical ventilation through a tracheotomic cuffed tube? A controlled randomized trial.
Secondary ID [1] 273594 0
NIL
Universal Trial Number (UTN)
Trial acronym
TRACHEOCHECK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
weaning failure 279390 0
Condition category
Condition code
Respiratory 285569 285569 0 0
Other respiratory disorders / diseases
Neurological 286234 286234 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post-neurosurgical and neurologic tracheotomized patients receiving mechanical ventilation will be randomized to receive either protocolized weaning protocol (intervention group) or a liberal weaning process according to the attending physicians’ clinical judgment (control group). In the intervention group, physiologic and clinical data collected in a systematic fashion by means of a written flow chart and a subsequent spontaneous breathing trial will determine if the patient will be disconnected from the ventilator.
The patients in the intervention group will be daily subjected to a spontaneous breathing trial consisting in a 30 min trial connected to the ventilator at 2 cmH2O of positive end expiratory pressure (PEEP). At the end of the 30 min a blood gas will be taken and the patient will be disconnected to the ventilator only if: the rapid shallow breathing index (ratio between respiratory rate and tidal volume) less than or equal to 105, the ratio between partial pressure of oxygen and fraction of inspired oxygen (PaO2/FiO2) greater or equal to 200 mmHg, and pH greater or equal to 7.35 with a PaCO2 less than or equal to 50 mmHg. If during the spontaneous breathing trial the patient will present any of these criteria i.e., breathing frequency greater than 35 breath/min; respiratory distress; SpO2 less than 90%; systolic blood pressure less than 90 or greater than 180 mmHg; heart rate greater than 140 bpm; deterioration of 2 points in the Glasgow Coma Scale, the spontaneous breathing trial will be interrupted and PEEP and Pressure Support will be set as before the weaning trial.
Intervention code [1] 283882 0
Treatment: Other
Comparator / control treatment
Control Group: The physician in charge will check daily patients for readiness to be disconnected to the ventilator. Despite the physician in charge will have available all the clinical information on rapid shallow breathing index, ratio between respiratory rate and tidal volume, pH and pCO2, the decision to disconnect the patient from the ventilator will depend not on a protocolized patient performance during the spontaneous breathing trial, but only on clinical judgment.
Control group
Active

Outcomes
Primary outcome [1] 286131 0
Reduction (%) of weaning failure.
The weaning failure will be defined as number of patients who are reconnected to the ventilator in the following 48 hours after the disconnection over the total number of patients. As we expect a reduction of weaning failure in the Intervention group, the difference between the percentage of weaning failure between the Control and Intervention groups will be the Reduction (%) of weaning failure.
These data, can be assessed by looking at the medical records database available in our hospital.
Timepoint [1] 286131 0
First 48 hours after disconnection from ventilator
Secondary outcome [1] 295207 0
Hours of invasive mechanical ventilation.
In both groups, the hours of invasive mechanical ventilation will be counted from the enrolment (i.e., from the moment the hemodynamic, neurologic and respiratory parameters will be stable to allow the physician in charge to check daily the patient for readiness to be disconnected to the ventilator) to the discharge to the ICU or up to 28 days in the Intensive Care Unit.
These data, can be assessed by looking at the bedside chart data.
Timepoint [1] 295207 0
28 days after randomization.
Secondary outcome [2] 295208 0
In both groups, the length of stay in the Intensive Care Unit will be calculated as the number of days from the entrance to the discharge of the patient.
These data, can be assessed by looking at the medical records database available in our hospital.
Timepoint [2] 295208 0
Days from the Intensive Care Unit entrance to the Intensive Care Unit discharge of the patient.
Secondary outcome [3] 295209 0
Length of stay in hospital (days)
In both groups, the length of stay in the hospital will be calculated as the number of days from the entrance to the discharge of the patient from the hospital.
These data, can be assessed by looking at the medical records database available in our hospital.
Timepoint [3] 295209 0
Days from the hospital entrance to the hospital discharge of the patient.
Secondary outcome [4] 295210 0
Mortality in Intensive Care Unit
In both groups, we will count the number of patients that die in the Intensive Care Unit.
This data, can be assessed by looking at the medical records database available in our hospital.
Timepoint [4] 295210 0
Mortality in Intensive Care Unit.
Secondary outcome [5] 295211 0
Mortality in the Hospital.
In both groups, we will count the number of patients that die after ICU discharge but still admitted in the same hospital.This data, can be assessed by looking at the medical records database available in our hospital.
Timepoint [5] 295211 0
Mortality in the Hospital.

Eligibility
Key inclusion criteria
Patients wii be included if:
1) admitted for neurologic disorders;
2) age > 18 years,
3) mechanical ventilation >12 hours,
4) no need for continuous sedative infusion and/or controlled mechanical ventilation;
5) ability to trigger the ventilator;
6) presence of tracheotomy.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) preexisting decision to limit life support.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer-generated randomization list will be prepared by the statistician. Based on the list sequentially numbered sealed opaque envelopes containing cards with group assignments will be prepared by the statistician who is not involved in patients enrollment. These sealed envelopes marked with the patients' sequential numbers are kept at the ICU department. When a patient is enrolled and written informed consent obtained, the physician in charge of the patient opens the envelope with the lowest number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by computer software (computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4006 0
Italy
State/province [1] 4006 0

Funding & Sponsors
Funding source category [1] 284365 0
Self funded/Unfunded
Name [1] 284365 0
Address [1] 284365 0
Country [1] 284365 0
Italy
Primary sponsor type
University
Name
Universita del Piemonte Orientale “Amedeo Avogadro”, Alessandria-Novara-Vercelli
Address
Via Solaroli 17, 28100 Novara
Country
Italy
Secondary sponsor category [1] 283304 0
None
Name [1] 283304 0
Address [1] 283304 0
Country [1] 283304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286326 0
Comitato Etico Interaziendale A.O.U. "Maggiore della Carita" ASL BI, ASL NO, ASL VC, ASL VCO
Ethics committee address [1] 286326 0
Corso Mazzini 18, 28100 Novara
Ethics committee country [1] 286326 0
Italy
Date submitted for ethics approval [1] 286326 0
Approval date [1] 286326 0
04/02/2011
Ethics approval number [1] 286326 0
CE 21/11

Summary
Brief summary
Introduction: Although a life-saving intervention, mechanical ventilation is apt to unwanted side-effects and complications and should be interrupted as soon as possible. In acutely brain-injured patients, delaying weaning and liberation from mechanical ventilation increase the rate of ventilator-associated pneumonia, septic complications, and mortality. In neurologic and neurosurgical intubated patients, a systematic assessment of the patient’s potential to be weaned off the ventilator has been demonstrated to reduce the risk of re-intubation following extubation failure, compared to the sole physician’s clinical judgment.
Objective: We undertook this multicentre randomized controlled trial to evaluate whether a systematic approach to weaning is superior to the physician’s judgment in preventing weaning failure occurring within 48 hours, in neurologic patients undergoing mechanical ventilation through a tracheotomic cuffed tube.
Methods: neurosurgical and neurologic tracheotomized patients receiving mechanical ventilation will be randomized to receive either protocolized weaning protocol (intervention group, IG) or a liberal weaning process according to the attending physicians’ clinical judgment (control group, CG). Although in this last group the decision are left entirely to the discretion of the physicians, all the information collected and recorded for the IG will be also available. The criteria for protocol failure i.e., reconnection to the ventilator, are defined a priori. Patients will be considered successfully weaned if they are not reconnected to the ventilator in the following 48 hours.
Trial website
Trial related presentations / publications
Evaluation of a systematic approach to weaning of tracheotomized neurological patients: an early interrupted randomized controlled trial.
Vaschetto R, Frigerio P, Sommariva M, Boggero A, Rondi V, Grossi F, Cavuto S, Nava S, Corte FD, Navalesi P.
Ann Intensive Care. 2015 Dec;5(1):54. doi: 10.1186/s13613-015-0098-0. Epub 2015 Dec 23
Public notes

Contacts
Principal investigator
Name 33526 0
Prof Paolo Navalesi
Address 33526 0
via Solaroli 17, 28100 Novara, Italy
Country 33526 0
Italy
Phone 33526 0
+3903213733406
Fax 33526 0
Email 33526 0
paolo.navalesi@med.uniupo.it
Contact person for public queries
Name 16773 0
Prof Paolo Navalesi
Address 16773 0
Department of Clinical and Experimental Medicine, Universita del Piemonte Orientale “Amedeo Avogadro”, Alessandria-Novara-Vercelli, Via Solaroli 17, 28100 Novara, Italy.
Country 16773 0
Italy
Phone 16773 0
+39,0321,3733406
Fax 16773 0
+39,0321,3733406
Email 16773 0
paolo.navalesi@fastwebnet.it
Contact person for scientific queries
Name 7701 0
Prof Paolo Navalesi
Address 7701 0
Department of Clinical and Experimental Medicine, Universita del Piemonte Orientale “Amedeo Avogadro”, Alessandria-Novara-Vercelli, Via Solaroli 17, 28100 Novara, Italy.
Country 7701 0
Italy
Phone 7701 0
+39,0321,3733406
Fax 7701 0
Email 7701 0
paolo.navalesi@fastwebnet.it

No information has been provided regarding IPD availability
Summary results
No Results