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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.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001244594
Enrollment
30
Registered
2015-11-12
Start date
2015-12-09
Completion date
2017-03-08
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 f

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).

Sponsors

Federico Longhini, MD
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026