Continuous Positive Pressure Versus Bi-level in Overlap Syndrome

NCT03766542 | Unknown

• 1 other identifier: OSPAP study
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Continuous positive airway pressure (CPAP) became the established treatment for overlap syndrome (OS). It has been showed that the survival benefits of CPAP favored hypercapnic patients. When considering hypercapnic stable COPD patients, survival benefits occurred when the use of bi- level ventilation therapy was targeted to significantly reduce hypercapnia. This highlights the relevance of hypercapnia and hypoventilation correction. Thus, the purpose of this study is to compare the use of CPAP to Bi-level ventilation in hypercapnic OS patients, since the later may correct not only the airway patency but also increase the magnitude of each breath.

Conditions

Overlap Syndrome; Nocturnal Hypoventilation

Outcome Measures

Primary Outcomes (2)

• diurnal hypercapnia (pCO2 <= 45 mmH2O )

  (PaCO2 \<= 45 mmH2O )

  1 year

• nocturnal oxygen desaturation correction

  Mean nocturnal SpO2 \>=90%, with \<10% of the total recording time \<90% after correction of leaks)

  1 year

Secondary Outcomes (12)

• Changes in FEV1

  1 year

• Changes in FVC

  1 year

• Changes in RV

  1 year

• exercise tolerance

  1 year

• Sleepiness evaluation

  1 year

Study Arms (2)

CPAP

ACTIVE COMPARATOR

Oronasal CPAP therapy applied as per current international guidelines

Device: continuous positive airway pressure without ventilatory support

Bi-level

EXPERIMENTAL

Oronasal Bi-level therapy + supplemental oxygen (if necessary) applied as per current international guidelines

Device: Bi-level positive airway pressure with ventilatory support

Interventions

Bi-level positive airway pressure with ventilatory support DEVICE

Positive airway pressure will be applied in the experimental group through a oronasal interface, in ventilatory support mode (Bi-level) with a fixed backup rate.

Bi-level

continuous positive airway pressure without ventilatory support DEVICE

Continuous positive airway pressure (CPAP) will be applied in the active comparator group through a oronasal interface.

CPAP

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD (FEV1/FVC \< 70 (post-BD) and history of smoking - 10 PPY)
• FEV1\< 80% and COPD symptoms
• AHI ≥ 15 events/hour

You may not qualify if:

• Persistent hypercapnic respiratory failure with acidosis (defined as pH \<7.30 after bronchodilators)
• Hypoxia requiring long term oxygen therapy
• BMI \> 35 kg/m2
• Previously-initiated long term non-invasive positive pressure ventilation
• Other lung disease resulting in respiratory symptoms
• Age \<40 years
• Pregnancy
• Malignant comorbidities
• Patients undergoing renal replacement therapy
• Restrictive lung disease causing hypercapnia
• Severe heart failure, unstable angina and severe arrhythmias
• Inability to comply with the protocol

Sponsors & Collaborators

• Hospital Sao Joao: lead
• Marta Drummond MD PhD: collaborator
• Joao Carlos Winck MD PhD: collaborator
• Mafalda van Zeller MD Phstud: collaborator

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Prospective randomized controlled trial.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: December 6, 2018
• Study Start: January 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 6, 2018

Record last verified: 2018-12