Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation

NCT04497090 | Completed

• 1 other identifier: Polimi
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effects of a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation. The investigators conducted a prospective, randomized, cross-over study on stable chronic obstructive pulmonary disease (COPD) patients. Patients were studied in the hospital during two non-consecutive nights while using either fixed or adaptive EPAP. The primary outcome was the transcutaneous partial pressure of carbon dioxide. Secondary outcomes were: oxygen saturation, breathing pattern, oscillatory mechanics, patient-ventilation asynchronies, sleep quality and sleep-related respiratory events.

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia; Ventilator Lung

Outcome Measures

Primary Outcomes (2)

• Mean transcutaneous partial pressure of carbon dioxide (PtcCO2)

  The partial pressure of carbon dioxide measures the efficacy of ventilation. Reducing PCO2 is the aim of nocturnal non-invasive ventilation in stable COPD patients with chronic hypercapnia. PCO2 is normally measured non-invasively using a transcutaneous probe during overnight studies.

  Overnight (about 8 hours)

• Percent of night time spent in hypercapnia

  Hypercapnia is defined as PtcCO2 \> 45 mm Hg. The aim of non-invasive ventilation in stable COPD patients is to reduce the time spent with PCO2 levels above the physiological range.

  Overnight (about 8 hours)

Secondary Outcomes (10)

• Mean peripheral oxygen saturation (SpO2)

  Through study completion, an average of 8 hours

• Desaturation

  Through study completion, an average of 8 hours

• Number of ineffective efforts per hour (IE)

  Through study completion, an average of 8 hours

• Sleep quality

  Through study completion, an average of 8 hours

• EPAP

  Through study completion, an average of 8 hours

Study Arms (2)

Fixed-EPAP

ACTIVE COMPARATOR

EPAP was kept fixed at the prescribed level throughout the night

Device: fixed-EPAP

Auto-EPAP

EXPERIMENTAL

EPAP was continuously adjusted using the experimental approach aimed at abolishing tidal expiratory flow limitation

Device: auto-EPAP

Interventions

fixed-EPAP DEVICE

In the fixed-EPAP mode, the device kept EPAP fixed at the prescribed value

Fixed-EPAP

auto-EPAP DEVICE

In the Auto-EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.

Auto-EPAP

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate to severe COPD (GOLD 2017);
• long-term users of nocturnal non-invasive ventilation for chronic hypercapnic respiratory failure;
• presence of tidal expiratory flow limitation in the supine position at an expiratory positive airway pressure of 4 cmH2O.

You may not qualify if:

• COPD exacerbation within the past two months;
• acute illness;
• clinical instability.

Sponsors & Collaborators

• Politecnico di Milano: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• Philips Healthcare: collaborator

Study Sites (1)

Divisione di Pneumologia, Fondazione S. Maugeri, IRCCS

Lumezzane, BS, Italy

Location

Related Publications (2)

• Milesi I, Porta R, Barbano L, Cacciatore S, Vitacca M, Dellaca RL. Automatic tailoring of the lowest PEEP to abolish tidal expiratory flow limitation in seated and supine COPD patients. Respir Med. 2019 Aug;155:13-18. doi: 10.1016/j.rmed.2019.06.022. Epub 2019 Jun 23.

  PMID: 31276979 BACKGROUND

• Zannin E, Milesi I, Porta R, Cacciatore S, Barbano L, Trentin R, Fanfulla F, Vitacca M, Dellaca RL. Effect of nocturnal EPAP titration to abolish tidal expiratory flow limitation in COPD patients with chronic hypercapnia: a randomized, cross-over pilot study. Respir Res. 2020 Nov 18;21(1):301. doi: 10.1186/s12931-020-01567-x.

  PMID: 33208164 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Raffaele L Dellacà, Prof.

  Politecnico di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: August 4, 2020
• Study Start: October 23, 2014
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)