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.

Not Applicable

Completed

• Conditions: Acute exacerbation of chronic respiratory failure; Respiratory - Chronic obstructive pulmonary disease; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12615001244594
• Lead Sponsor: Federico Longhini, MD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate if in patients recovering from SE-CRF, the respiratory effort varies between treatments, as assessed through the diaphragm ultrasonogaphy.[At the end of each trial, recording the diaphragm thickening fraction (TF) and displacement with the ultrasound.]

Secondary Outcome Measures

Name	Time	Method
Evaluation of gas exchanges as assessed by an arterial blood sample.[At the end of each trial.];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.[At the end of each trial.];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.[At the end of each trial]