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Comfort and safety of an adapted mask versus an orofacial mask in postoperative heart surgery patients

Comfort and safety of the owner mask in relation to the conventional orofacial mask in post-operative heart surgery patients: a pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2zky4p9
Enrollment
Unknown
Registered
2022-01-27
Start date
2021-05-03
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Patients in the postoperative period of cardiac surgery for valve replacement or myocardial revascularization Descriptor: Thoracic Surgery

Interventions

This is a randomized clinical trial, in which individuals will be randomized into two groups, one that will use a conventional orofacial mask (VNI Orofacial Group, 40 patients) and another that will u
E02.041.625.591

Sponsors

Universidade de Santa Cruz do Sul
Lead Sponsor
Hospital Santa Cruz
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients admitted to the ICU for post-operative care after CABG or TV from May to October 2021. Patients of both sexes. Age between 18 and 80 years. Indication of institution of non-invasive ventilation after extubation. Preserved cognitive ability to understand the proposed tests.

Exclusion criteria

Exclusion criteria: Comatose patients (Glasgow Coma Scale <8). Patients who refuse to receive non-invasive ventilation. Presence of facial anomalies, facial trauma and facial burns. Presentation of vomiting and severe hematemesis. Massive hemoptysis. Hemodynamically unstable patients Mental confusion. Patients who do not sign the Informed Consent Form (FICF)

Design outcomes

Primary

MeasureTime frame
Compare the safety and comfort of the adapted diving mask (Owner mask) in relation to the conventional orofacial mask for the institution of NIV in patients after surgery cardiac arrest.

Secondary

MeasureTime frame
To characterize patients undergoing valve replacement and myocardial revascularization surgery regarding clinical, laboratory and imaging data, ejection fraction, sociodemographic and anthropometrics, perception of pain and exertion, clinical severity and comorbidities. Assess peripheral oxygen saturation (SpO), blood pressure (BP), heart rate (HR) and respiratory rate (RR) before and after the institution of NIV using an Onwer mask and a conventional orofacial mask in patients undergoing valve replacement and myocardial revascularization surgery. To assess blood pressure and incidence of hypotension after 30 minutes of NIV application using an Onwer mask and a conventional orofacial mask in patients undergoing valve replacement and myocardial revascularization surgery. Assess the degree of comfort of the Owner mask and the conventional orofacial mask in patients submitted to valve replacement and myocardial revascularization surgery. Assess the level of satisfaction after using the Owner mask and the conventional orofacial mask in the NIV of patients in patients undergoing valve replacement and myocardial revascularization surgery. Register complications related to the Owner mask and the conventional orofacial mask: pain, leakage, pressure, oronasal dryness, skin irritation and claustrophobia in patients undergoing valve replacement and myocardial revascularization surgery.

Countries

Brazil

Contacts

Public ContactEduarda Silveira
eduarda.chaves.silveira@gmail.com+55(51)995532631

Outcome results

None listed

Source: REBEC (via WHO ICTRP)