ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12615001244594

Ethics application status

Approved

Date submitted

11/09/2015

Date registered

12/11/2015

Date last updated

27/03/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparative physiological evaluation with diaphragmatic ultrasound of the application of two different oxygen-therapy techniques in patients recovering from severe exacerbation of chronic respiratory failure.

Scientific title

Comparative physiological evaluation with diaphragmatic ultrasound of the application of oxygen-therapy through a Venturi mask or a nasal high-flow device in patients recovering from severe exacerbation of chronic respiratory failure.

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Acute exacerbation of chronic respiratory failure

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

After obtaining written informed consent, the patient will undergo to 5 consecutive 30-minute trials: 1) Non-Invasive Ventilation (NIV_1); 2) Venturi mask; 3) Non-Invasive Ventilation (NIV_2); 4) Optiflow; 5) Non-Invasive Ventilation (NIV_3).
The sequence of Venturi mask and Optiflow trials will be randomized, according to a sequence generated by a computer. During non-invasive ventilation (NIV) trials (NIV_1, NIV_2 and NIV_3), the inspiratory support will be given with a dedicated ventilator for NIV, in Pressure Support Ventilation mode, through a mask, as clinically indicated. The Optiflow will be initially set with the highest flow value between 50-60 L/min, according to the patient's tolerance. The nasal cannula size will be appropriately chosen. Moreover, the temperature of the heater will be set at 37 degrees
During all trials, FiO2 will be kept unchanged, in order to assure an arterial saturation in O2 > 94% (SpO2).

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The Optiflow will be compared with the application of simple Oxygen therapy delivered throughout a Venturi mask with a nominal FiO2 equal to those set during NIV and Optiflow trials. The L/min of Oxygen will be modified according to the nominal FiO2 required and to the Venturi kit used.

Control group

Active

Outcomes

Primary outcome [1]

To evaluate if in patients recovering from SE-CRF, the respiratory effort varies between treatments, as assessed through the diaphragm ultrasonogaphy.

Timepoint [1]

At the end of each trial, recording the diaphragm thickening fraction (TF) and displacement with the ultrasound.

Secondary outcome [1]

Evaluation of gas exchanges as assessed by an arterial blood sample.

Timepoint [1]

At the end of each trial.

Secondary outcome [2]

Evaluation of patient's comfort as assessed through a 11-point Numeric Rating Scale (NRS). The patient will be ask to evaluate, after having received a proper explication of the NRS before the initiation of study protocol.

Timepoint [2]

At the end of each trial.

Secondary outcome [3]

Evaluation of patient's dyspnoea as assessed through a 11-point Numeric Rating Scale (NRS). The patient will be ask to evaluate, after having received a proper explication of the NRS before the initiation of study protocol.

Timepoint [3]

At the end of each trial

Eligibility

Key inclusion criteria

All the patients meeting the following criteria will be eligible for the study: 1) age equal or greater than 18 years; 2) presence of consciousness; 3) previous NIV for at least 24 hours due to SE-CRF; 4) pH greater than 7.34; 5) respiratory rate (RR) less than or equal to 30 breaths/min.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients will be excluded if they meet one or more of the following criteria:
1. refusal of patient's consent;
2. Hemodynamic instability, as defined by a systolic blood pressure < 90 mmHg despite volemic optimizationn, or use of vasoactive agents, i.e. vasopressin or epinephrine at any dosage, norepinephrine > 0.2 mcg/kg/min, dopamine or dobutamine > 5 mcg/kg/min;
3. major cardiac arrhythmia or electrographic signs of ischemia;
4. use of accessory muscles with dyspnoea;
5. pregnancy.

The protocol will be interrupted if:
1. agitation or mental status alteration
2. increase use of accessory muscles and/or dyspnoea
3. pH < 7.30
4. systolic blood pressure < 90 mmHg
5. onset of new cardiac arrhythmia

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)

Everyday all patients admitted in our intensive care unit will be screened for meeting inclusion criteria. The randomization sequence for the cross-over design is contained in sealed opaque envelopes, in the office of the director of the ICU. When the patient is enrolled, a nurse or a doctor not involved in the study is asked to take the envelopes and read to the investigator the randomization sequence for Venturi and Optiflow.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

We will use a computer-generated randomization sequence, which will be generated by an independent statistician who is not otherwise involved in the trial. The envelopes will be kept in the head nurses’ office. The nurses who open the envelopes will be those on shift and will be totally independent from the enrollment process. They will communicate the random treatment allocation to the physician responsible for the patient enrollment.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Due to the lack of previous data, it is not possible to compute an adequate sample size. However, we believe that a total of 30 patients could be sufficient for the purpose of the study.
The normal distribution will be evaluated with a Kolmogorov-Smirnov test. Data will be analyzed with the Analysis of Variance for repeated measure (ANOVA); when indicated, a Bonferroni post hoc test will be applied. P values <0.05 will be considered for statistical differences.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/12/2015

Actual

9/12/2015

Date of last participant enrolment

Anticipated

Actual

8/03/2017

Date of last data collection

Anticipated

Actual

8/03/2017

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Vercelli

Country [2]

Italy

State/province [2]

Bari

Country [3]

Italy

State/province [3]

Bologna

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Federico Longhini, MD

Address [1]

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country [1]

Italy

Primary sponsor type

Individual

Name

Federico Longhini, MD

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Committee Alessandria

Ethics committee address [1]

Via Venezia 16, 15121, Alessandria

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

20/05/2015

Approval date [1]

16/07/2015

Ethics approval number [1]

AslVC.Rian.15.01

Summary

Brief summary

In patients affected by severe exacerbation of chronic respiratory failure (SE-CRF), with worsened hypercapnia and respiratory  acidosis, the sole oxygen therapy is not enough and a ventilatory assistance is required, most of the time through a mask or helmet, so call non-invasive ventilation. The advantage of NIV is to guarantee a ventilatory assistance, avoiding complications related to the presence of the endotracheal tube, such as ventilator associated pneumonia. Furthermore, it has been widely shown that, in patients with SE-CRF, NIV reduces the mortality rate, as opposed to invasive mechanical ventilation.
However, NIV is a "bridge-therapy", applied in the attempt to permit the pharmacological treatments (i.e. antibiotics and bronchodilators) solve the underlying reason of exacerbation; afterwards, patients can be weaned from NIV, and, whenever required, starts oxygen therapy.
Among devices for oxygen therapy, Venturi mask is frequently used in Intensive Care Unit (ICU), because it is possible to provide a nominal fraction of inspired oxygen (FiO2) between 24 and 60%. Recently a new device has become commercially available (Optiflow, Fisher & Paykel, New Zealand) able to provide high flow of heated and humidified gas through nasal cannula. The humidification of gas flow reduces the risk of mucosa dryness and airway muco-ciliar clearence. The use of high-flow of gas (up to 60L/min) permits to provide accurate FiO2 during all the inspiratory phase and to wash out the naso-pharyngeal dead space, in addition to the application of a minimal positive pressure. In patients with hypoxemic acute respiratory failures of mild to moderate degree, Optiflow has been shown to be better tolerated and to guarantee a better oxygenation, in comparison with Venturi mask. Moreover, in another study a high-flow oxygen-therapy system has been shown to reduce the respiratory rate in patients with CRF and the arterial partial pressure of carbon dioxide (PaCO2). 
Basing on these data, the Optiflow system could potentially positively influence the inspiratory effort of patients experiencing SE-CRF, when compared to Venturi mask.
Though both commonly used in clinical practice, nowadays no study has compared Optiflow with Venturi mask at this regard.
We aim to evaluate if some differences in respiratory effort exists between Venturi mask and Optiflow, in patients recovering from SE-CRF, through a diaphragm ultrasonogaphy evaluation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+393475395967

Fax

longhini.federico@gmail.com

Contact person for public queries

Name

Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+393475395967

Fax

longhini.federico@gmail.com

Contact person for scientific queries

Name

Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+393475395967

Fax

longhini.federico@gmail.com

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	High-Flow Oxygen Therapy after Noninvasive Ventilation Interruption in Patients Recovering from Hypercapnic Acute Respiratory Failure.	2019	https://dx.doi.org/10.1097/CCM.0000000000003740

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically