ANZCTR - Registration

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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]

NIL

Universal Trial Number (UTN)

Trial acronym

TRACHEOCHECK

Linked study record

Health condition

Health condition(s) or problem(s) studied:

weaning failure

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Neurological

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]

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]

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]

First 48 hours after disconnection from ventilator

Secondary outcome [1]

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]

28 days after randomization.

Secondary outcome [2]

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]

Days from the Intensive Care Unit entrance to the Intensive Care Unit discharge of the patient.

Secondary outcome [3]

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]

Days from the hospital entrance to the hospital discharge of the patient.

Secondary outcome [4]

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]

Mortality in Intensive Care Unit.

Secondary outcome [5]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/03/2011

Actual

1/03/2011

Date of last participant enrolment

Anticipated

Actual

31/12/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

280

Accrual to date

Final

168

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comitato Etico Interaziendale A.O.U. "Maggiore della Carita" ASL BI, ASL NO, ASL VC, ASL VCO

Ethics committee address [1]

Corso Mazzini 18, 28100 Novara

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

Approval date [1]

04/02/2011

Ethics approval number [1]

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

Prof Paolo Navalesi

Address

via Solaroli 17, 28100 Novara, Italy

Country

Italy

Phone

+3903213733406

Fax

[email protected]

Contact person for public queries

Name

Prof Paolo Navalesi

Address

Department of Clinical and Experimental Medicine, Universita del Piemonte Orientale “Amedeo Avogadro”, Alessandria-Novara-Vercelli, Via Solaroli 17, 28100 Novara, Italy.

Country

Italy

Phone

+39,0321,3733406

Fax

+39,0321,3733406

[email protected]

Contact person for scientific queries

Name

Prof Paolo Navalesi

Address

Department of Clinical and Experimental Medicine, Universita del Piemonte Orientale “Amedeo Avogadro”, Alessandria-Novara-Vercelli, Via Solaroli 17, 28100 Novara, Italy.

Country

Italy

Phone

+39,0321,3733406

Fax

[email protected]

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Evaluation of a systematic approach to weaning of tracheotomized neurological patients: an early interrupted randomized controlled trial.	2015	https://dx.doi.org/10.1186/s13613-015-0098-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically