Status:
WITHDRAWN
"Post-acute Pickwick Study" (Postacute-Pick-2020)
Lead Sponsor:
Juan F. Masa
Collaborating Sponsors:
Rush University Medical Center
Conditions:
Acute on Chronic Hypercapnic Respiratory Failure
Obesity Hypoventilation Syndrome (OHS)
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized pa...
Detailed Description
Objectives: First phase (medium-term): To evaluate the medium-term (3 months) efficacy of automatically adjusted noninvasive ventilation (NIV) treatment versus "life style modifications" treatment in ...
Eligibility Criteria
Inclusion
- º.- Patient between 18 and 85 years old.
- º.- With diagnosis of OHS (according to Obesity (BMI ≥30 kg/m2) and Hypercapnic respiratory failure (PaCO2 ≥45 mmHg at hospital discharge) not secondary to other causes.
- º - Hospitalized for an episode of acute-on-chronic hypercapnic respiratory failure, receiving hospital therapy with invasive or noninvasive ventilation, and just deemed stable for home discharge."
- º.- No NIV or CPAP home therapy in the last 6 months\[\*\].
- º.- Being able to tolerate and correctly execute a 15-minute test with automatic NIV (AVAPS-AE) and another 15-minute test with fixed CPAP treatments during wakefulness.
- º.- Providing informed consent (dated and signed).
- \[\*\] Patients who have objective evidence of minimal PAP therapy during the 6 months prior to hospital admission (i.e. average daily use of less than 2 hours of PAP therapy) can also be enrolled at the discretion of the investigators if they feel the patient is now more interested in being adherent to NIV therapy.
- Inclusion criteria for the second phase of the study:
- 1º.- Included three months ago in the first phase of the study (followed by a washout period of 5 days).
Exclusion
- Exclusion criteria for the first phase of the study:
- º.- With moderate or severe chronic obstructive pulmonary disease (FEV1\<70% of predicted when FEV1/FVC is below 70%).
- º.- With neuromuscular disease, thoracic wall or metabolic disease that may cause diurnal hypercapnia.
- º.- Inability to maintain a patent airway or adequately clear secretions.
- º.- With bullous lung disease or with pneumothorax.
- º.- With bypassed upper airway (i.e. endotracheal tube or tracheostomy).
- º.- With anatomical abnormalities of the craniofacial structure leading to cerebral spinal fluid leaks, abnormalities of the cribriform plate, and/or pneumocephalus.
- º.- At risk for aspiration of gastric contents.
- º.- Diagnosed with acute sinusitis or otitis media.
- º.- With active hemoptysis or epistaxis if presenting a risk of causing pulmonary aspiration of blood.
- º.- With symptomatic hypotension.
- º.- With clinical diagnosis of narcolepsy or restless leg syndrome.
- º.- Psycho-physical incapacity to complete questionnaires.
- º.- With diagnosis of chronic illness that might interfere the evaluation using quality of life questionnaires (neoplasia, severe chronic pain of any type, and any other severe chronic debilitating illness).
- º.- Suffering other clinically relevant disease that, under the opinion of the investigator, might affect the evaluations of efficacy or safety.
- º.- Participating simultaneously in other clinical study with intervention (or without intervention at the discretion of the investigator and with the consent of the Sponsor) or had participated in other clinical study with intervention within the last 30 days before the inclusion in this study. \[‡\]
- º.- If for any reason (planned surgery \[including bariatric surgery\], trips of long duration, etc.) would not be able to receive the treatment and/or attend the follow-up visits of this study within the next three years and three months.
- º.- Persons deprived of liberty by judicial or administrative decision, persons under psychiatric treatment and persons placed in a health or social institution for purposes other than those of this clinical study.
- º.- Adults who are subject to a legal protection measure or who are unable to express their consent.
- \[‡\] This prohibition shall be maintained for the duration of the patients' participation in the study. This is because, if patients received other treatments, it could be difficult to interpret the causality of the results obtained (whether beneficial or harmful effects) and the possible contraindications.
- vi. Exclusion criteria for the second phase of the study:
- 1º.- With apnea hypopnea index (AHI) lower than 5 (absence or very mild obstructive sleep apnea).
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2029
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04317326
Start Date
January 1 2023
End Date
December 1 2029
Last Update
May 11 2023
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