Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-06-06 @ 6:02 PM
Study NCT ID:
NCT06805357
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Evaluation of Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECRUTKI
Brief Summary:
In intensive care, respiratory physiotherapy is an integral part of the daily care of patients under invasive mechanical ventilation. Its goals are to improve the clearance of bronchial secretions to allow for the resolution of atelectasis and alveolar recruitment, thereby enhancing respiratory mechanics and gas exchange. The most widespread technique in France is external expiratory compression of the chest.
The effectiveness of this technique depends on the selection of patients (it seems to be more effective in patients with higher secretion levels) and on the practical implementation of the technique (favoring brief and vigorous compressions at the beginning of expiration). However, the effect of the artificial ventilator settings, particularly the ventilatory mode used during the respiratory physiotherapy session, has never been evaluated. The two most commonly used ventilatory modes worldwide are Volume Assist Control Ventilation (V-ACV) and pressure support ventilation (PSV). In this unit, respiratory physiotherapy under artificial ventilation is performed daily on patients with artificial ventilation with abundant secretions, regardless of the ventilatory mode.
The effectiveness of this technique depends on the selection of patients (it seems to be more effective in patients with higher secretion levels) and on the practical implementation of the technique (favoring brief and vigorous compressions at the beginning of expiration). However, the effect of the artificial ventilator settings, particularly the ventilatory mode used during the respiratory physiotherapy session, has never been evaluated. The two most commonly used ventilatory modes worldwide are Volume Assist Control Ventilation (V-ACV) and pressure support ventilation (PSV). In this unit, respiratory physiotherapy under artificial ventilation is performed daily on patients with artificial ventilation with abundant secretions, regardless of the ventilatory mode.
Detailed Description:
It is hypothesized that the effectiveness of respiratory physiotherapy on recruitment depends on the ventilatory mode used during the session.
The primary objective is to compare pulmonary recruitment during respiratory physiotherapy in patients under invasive mechanical ventilation between sessions performed in V-ACV and PSV.
Secondary objectives are to compare the effects of respiratory physiotherapy between V-ACV mode and PSV mode on respiratory mechanics, gas exchange, the amount of drained secretions (weight and volume), the distribution of ventilation, and patient tolerance.
Method:
A cross-over study with a non-invasive physiological endpoint. The primary evaluation criterion is variations in end-expiratory lung volume (ΔEELV) measured 5 minutes before and 5 minutes after a standardized respiratory physiotherapy session in V-ACV or PSV.
The tool used to measure End Expiratory Lung Volume (EELV) is the additional module E-sCOVX of the CARESCAPE R860 ventilator. The procedure is automated and is based on a dilution method.
Secondary outcomes aim to evaluate regional lung ventilation distribution, respiratory mechanics, airway clearance, gas exchange, and patient tolerance.
Tools used to measure secondary evaluation criteria include Electrical Impedance Tomography (EIT) Pulmovista 500® (Dräger), a Pneumotachograph with a pressure transducer inserted in the ventilator circuit (MP150, Biopac Systems, Inc.), and a trap to collect mucus.
The intervention consists of a standardized session in a standardized position (supine at 35° of head elevation).
Each session is composed of 7 series of 3 Rib Cage Compressions (RCC) in a row during each expiration, applied to the thorax only. The interval between the series is about 10 respiratory cycles.
The 2 sessions are done on the same day. One session is performed in the morning, the other in the afternoon. One session is performed in V-ACV and the other in PSV. The order is randomized.
Conclusion:
The results of this study will help better understand the effects of RCC according to the ventilatory mode in patients under invasive mechanical ventilation with mucus excess.
The primary objective is to compare pulmonary recruitment during respiratory physiotherapy in patients under invasive mechanical ventilation between sessions performed in V-ACV and PSV.
Secondary objectives are to compare the effects of respiratory physiotherapy between V-ACV mode and PSV mode on respiratory mechanics, gas exchange, the amount of drained secretions (weight and volume), the distribution of ventilation, and patient tolerance.
Method:
A cross-over study with a non-invasive physiological endpoint. The primary evaluation criterion is variations in end-expiratory lung volume (ΔEELV) measured 5 minutes before and 5 minutes after a standardized respiratory physiotherapy session in V-ACV or PSV.
The tool used to measure End Expiratory Lung Volume (EELV) is the additional module E-sCOVX of the CARESCAPE R860 ventilator. The procedure is automated and is based on a dilution method.
Secondary outcomes aim to evaluate regional lung ventilation distribution, respiratory mechanics, airway clearance, gas exchange, and patient tolerance.
Tools used to measure secondary evaluation criteria include Electrical Impedance Tomography (EIT) Pulmovista 500® (Dräger), a Pneumotachograph with a pressure transducer inserted in the ventilator circuit (MP150, Biopac Systems, Inc.), and a trap to collect mucus.
The intervention consists of a standardized session in a standardized position (supine at 35° of head elevation).
Each session is composed of 7 series of 3 Rib Cage Compressions (RCC) in a row during each expiration, applied to the thorax only. The interval between the series is about 10 respiratory cycles.
The 2 sessions are done on the same day. One session is performed in the morning, the other in the afternoon. One session is performed in V-ACV and the other in PSV. The order is randomized.
Conclusion:
The results of this study will help better understand the effects of RCC according to the ventilatory mode in patients under invasive mechanical ventilation with mucus excess.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: