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Positive pressure during hemodialysis and its impact on the lungs and circulation: a clinical study

Effects of Positive Pressure during the intradialytic period on Pulmonary Congestion and hemodynamic parameters: a randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3f6xgk7
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-08-20
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Pulmonary Edema

Interventions

This is a randomized, controlled clinical trial with a cross-over design. Single blind. Continuous positive airway pressure (CPAP) will be administered via a facial mask during a hemodialysis session.

Sponsors

Universidade de São Paulo
Lead Sponsor
Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults aged equal to or greater than eighteen years, of both sexes, with a diagnosis of Chronic Kidney Disease undergoing regular hemodialysis treatment for at least three months; with dialysis sessions lasting two to four hours, three times per week, in a hospital-based hemodialysis center; clinically stable; without recent infections or decompensations; and able to understand and sign the Informed Consent Form

Exclusion criteria

Exclusion criteria: Patients with absolute contraindication to the use of positive pressure; those with cognitive and or physical impairments that prevent the performance of the tests and assessments proposed in the protocol; those with congestive heart failure classified as class three or four according to the New York Heart Association; with chronic atrial fibrillation; participants of daily hemodialysis programs; pregnant women and or individuals with cardiac pacemakers; and patients unable to tolerate the use of a facial mask and positive pressure due to claustrophobia, anxiety, or respiratory discomfort will be excluded from the study

Design outcomes

Primary

MeasureTime frame
A reduction in pulmonary congestion is expected after the use of continuous positive airway pressure (CPAP) during the hemodialysis session, assessed through lung ultrasonography, using the total number of B-lines observed before and after the intervention as a parameter, with a significant reduction in B-lines indicating improvement in pulmonary congestion

Secondary

MeasureTime frame
A reduction in respiratory rate and heart rate is expected during and after continuous positive airway pressure (CPAP) use, assessed through continuous multiparameter monitoring, with significant mean variations from baseline values indicating improvement in respiratory and hemodynamic patterns ;An increase in peripheral oxygen saturation (SpO2) is also expected during the session with CPAP use, measured by continuous pulse oximetry, with an average rise equal to or greater than two percentage points compared to baseline values, indicating improved oxygenation;The level of tolerance and discomfort associated with noninvasive ventilation will be evaluated using a visual analog scale (VAS), with lower scores indicating greater tolerance to continuous positive airway pressure (CPAP) use ;Systolic and diastolic blood pressure will be measured before and after the intervention using a calibrated digital blood pressure monitor, and a mean post-intervention reduction compared to baseline values is expected, without occurrence of symptomatic hypotension ;Finally, early discontinuation of continuous positive airway pressure (CPAP) use due to intolerance will be assessed, recorded through direct observation and notation in the clinical chart, considering the proportion of patients who discontinue use before 60 minutes as an indicator of low tolerability to the intervention ;A comparison between pre- and post-dialysis weights will be performed in sessions with and without continuous positive airway pressure (CPAP), assessed using a hospital-grade electronic scale, aiming to identify smaller post-dialysis weight differences during CPAP use, which may indicate better fluid removal and reduced pulmonary congestion

Countries

Brazil

Contacts

Public ContactFranciele Abdala

Universidade de São Paulo

franciele.anba@gmail.com+55 51 99104-5158

Outcome results

None listed

Source: REBEC (via WHO ICTRP)