Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05011877

The Simplify Project — SIMPLIFY  

Acute Hypercapnic Respiratory Failure Clinical Trial

Official title:
A Strategy to Improve Management and Prolong LIFe Without Readmission for hYpercapnic Patients: The Simplify Project

Clinical Trial Summary

The high frequency of unplanned hospital visits of patients with chronic hypercapnic respiratory failure (e.g., chronic obstructive pulmonary disease, obesity-related hypoventilation) constitutes a major public health problem. Most patients admitted for acute exacerbations (AHRF) have additional comorbidities, especially sleep disorders. Often untreated, sleep disorders contribute to multiple readmissions (≈70% at one year) and increase readmission costs. The investigators will: 1) identify these patients early during unplanned hospital admissions and perform sleep studies using EEG and oximetry before hospital discharge and two months after to compare sleep abnormalities in the two moments; 2) investigate the association between sleep abnormalities in the two sleep studies with clinical outcomes (1-year readmission and death); 3) investigate the acute effects of high-flow nasal cannula (HFNC) to treat sleep abnormalities as a simplified alternative. The investigators anticipate sleep abnormalities during the hospital stay and two months after discharge will be associated with poor clinical outcomes (readmission, death) and HFNC to acutely reduce sleep abnormalities.

Clinical Trial Description

The investigators will perform sleep studies using nocturnal EEG measurements and oximetry 1) while the participants are still in the hospital but have reached relative clinical stability (≥48 h after admission, not in ICU and pHv ≥7.36) and 2) two months after hospital discharge at the participant's home. Sleep studies will be performed from 5:00 pm to 8 am. EEG measurements will be performed using a portable monitor (Prodigy Sleep System, Cerebra, Winnipeg, Canada). Sleep assessment will be performed offline. The ORP will be continuously quantified and ORP-derived indices will be calculated. Nocturnal oximetry will be used for detecting sleep desaturation episodes. Comorbidities (e.g., obesity, diagnosed lung or heart disease, Charlson comorbidity index) and exacerbations/hospitalization in the previous year will be identified. In 21 participants, the investigators will perform one additional sleep study with the participants breathing with high-flow nasal cannula therapy (HFNC) to investigate the acute impact (i.e., during one night) of HFNC on reducing sleep abnormalities. HFNC will be set from 25 - 60 L/min based on participant's tolerance and the inspired fraction of oxygen will be titrated to maintain patient SpO2 similar to the levels during standard oxygen therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05011877
Study type Observational
Source Unity Health Toronto
Contact Laurent Brochard, MD, PhD
Phone 416-864-5686
Email Laurent.Brochard@unityhealth.to
Status Not yet recruiting
Phase
Start date September 1, 2021
Completion date July 1, 2024
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06007495 - Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout. N/A
Recruiting NCT02111876 - Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU N/A
Recruiting NCT03033251 - High Flow Nasal Cannula Versus Non-Invasive Ventilation in Exacerbations of Chronic Obstructive Pulmonary Disease N/A
Recruiting NCT02264626 - Sedation During Noninvasive Ventilation (NIV) N/A
Terminated NCT00213395 - Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure N/A
Not yet recruiting NCT05499039 - High Flow Nasal Cannula Versus Non-Invasive (NIV)in Both Hypoxemic and Hypercapnic Respiratory Failure. N/A
Completed NCT04102735 - Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF) N/A
Not yet recruiting NCT06064409 - Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study
Terminated NCT04650412 - Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit N/A
Active, not recruiting NCT06374589 - Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients (CLOUDHFOT) N/A
Recruiting NCT04640948 - High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure N/A
Completed NCT02538263 - Volume-targeted Versus Pressure-limited Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure N/A
Recruiting NCT06204276 - Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure N/A
Not yet recruiting NCT03756415 - CO2 Clearance During Noninvasive Ventilation (NIV) N/A
Recruiting NCT06108284 - Impact of Negative Pressure Ventilation in Patients Hospitalized With Acute Hypercapnic Respiratory Failure N/A
Not yet recruiting NCT05674760 - ReAcT CO2: A Study to Assess TcCO2 to Guide Acute NIV N/A
Recruiting NCT05513508 - The ROTAtional-USE of Interface STUDY N/A
Recruiting NCT03642002 - The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU N/A
Not yet recruiting NCT04362787 - High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
Completed NCT04109560 - HFNC and Acute Hypercapnic Respiratory Failure