- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07358039
Effect of Post-suction Recruitment on Lung Volume in Mechanically Ventilated ICU Patients (RESPIRE)
Impact of a Recruitment Maneuver After Closed Endotracheal Suctioning on End-expiratory Lung Volume in Mechanically Ventilated ICU Patients Assessed by Electrical Impedance Tomography
Patients who are intubated and mechanically ventilated in the intensive care unit (ICU) require repeated endotracheal suctioning to remove airway secretions. Although this procedure is necessary, it can cause a temporary collapse of lung units (alveolar derecruitment), leading to a decrease in lung volume and impaired oxygenation.
A recruitment maneuver consists of briefly applying a higher airway pressure after suctioning in order to reopen collapsed lung areas and restore lung volume. However, the clinical benefit of performing a recruitment maneuver systematically after suctioning remains uncertain.
This study aims to evaluate whether performing a recruitment maneuver immediately after closed-circuit endotracheal suctioning improves lung volume compared with suctioning alone. Lung volume will be assessed using electrical impedance tomography (EIT), a non-invasive bedside imaging technique that allows real-time monitoring of lung aeration.
In a randomized crossover design, each patient will undergo two suctioning procedures: one followed by a recruitment maneuver and one without, in a random order. The main outcome will be the change in end-expiratory lung volume 15 minutes after suctioning. The results may help optimize ventilatory care in mechanically ventilated ICU patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Endotracheal suctioning in mechanically ventilated ICU patients is a common procedure but is associated with alveolar derecruitment, resulting in a decrease in end-expiratory lung volume (EELV), deterioration of oxygenation, and potential lung injury.
A recruitment maneuver applied immediately after suctioning may reopen collapsed alveoli and restore lung volume, provided that sufficient positive end-expiratory pressure is maintained. However, available data are limited and conflicting, especially in adult ICU patients.
This prospective, randomized, open-label, single-center crossover trial will evaluate the physiological impact of a recruitment maneuver performed after closed-circuit endotracheal suctioning.
Each patient will receive two interventions in random order:
- Treatment A: closed-circuit endotracheal suctioning alone
- Treatment B: closed-circuit endotracheal suctioning followed immediately by a recruitment maneuver (airway pressure 30 cmH₂O for 30 seconds, with unchanged PEEP) Patients will be randomized to one of two sequences (AB or BA), with a 15-minute washout period between interventions.
Electrical impedance tomography (PulmoVista® V500) will be used to measure end-expiratory lung impedance, which reflects EELV. Functional residual capacity will be measured using nitrogen washout on a CARESCAPE R860 ventilator. Lung compliance and PaO₂/FiO₂ ratio will also be recorded.
Measurements will be obtained before suctioning and 15 minutes after each intervention. The primary endpoint is the percentage change in EELV at 15 minutes after suctioning between the two conditions.
A total of 32 mechanically ventilated ICU patients will be included.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Asmaa JOBIC, Ph.D
- Phone Number: +33 04 83 77 20 61
- Email: asmaa.jobic@ch-toulon.fr
Study Locations
-
-
VAR
-
Toulon, VAR, France, 83000
- Recruiting
- Hôpital National d'Instruction des Armées Sainte-Anne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged ≥18 years
- Covered by national health insurance
- Admitted to the intensive care unit
- Intubated and mechanically ventilated
- Neuromuscular blockade at inclusion
- Written informed consent obtained from a legally authorized representative or next of kin
Exclusion Criteria:
- Contraindication to electrical impedance tomography (e.g. pacemaker, implantable cardioverter-defibrillator, or implanted electrical stimulation device)
- Contraindication to recruitment maneuvers (e.g. emphysema, undrained pneumothorax, hemodynamic instability)
- Refractory intracranial hypertension
- Acute respiratory distress syndrome requiring prone positioning
- Pregnant or breastfeeding women
- Patients deprived of liberty or under legal protection
- Any condition judged by the investigator to interfere with study evaluation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
Patients undergo closed-circuit endotracheal suctioning without a recruitment maneuver.
|
Standard closed-circuit endotracheal suctioning performed for less than 15 seconds without disconnecting the ventilator.
|
|
Experimental: B
Patients undergo closed-circuit endotracheal suctioning immediately followed by a recruitment maneuver.
|
After suctioning, a recruitment maneuver is applied consisting of an airway pressure of 30 cmH₂O maintained for 30 seconds, without changing the positive end-expiratory pressure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage change in end-expiratory lung volume (EELV) after suctioning
Time Frame: 15 minutes after endotracheal suctioning
|
EELV assessed by end-expiratory lung impedance measured with electrical impedance tomography (PulmoVista® V500).
|
15 minutes after endotracheal suctioning
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lung compliance
Time Frame: Baseline and 15 minutes after suctioning
|
Measured from ventilator-derived respiratory mechanics.
|
Baseline and 15 minutes after suctioning
|
|
Change in functional residual capacity (FRC)
Time Frame: Baseline and 15 minutes after suctioning
|
Measured by nitrogen washout using the CARESCAPE R860 ventilator.
|
Baseline and 15 minutes after suctioning
|
|
Change in PaO₂/FiO₂ ratio
Time Frame: Baseline and 15 minutes after suctioning
|
Calculated from arterial blood gas analysis.
|
Baseline and 15 minutes after suctioning
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cyril PERNOD, MD, Hôpital National d'Instruction des Armées (HNIA) Sainte-Anne, Toulon
Publications and helpful links
General Publications
- Morrow B, Futter M, Argent A. A recruitment manoeuvre performed after endotracheal suction does not increase dynamic compliance in ventilated paediatric patients: a randomised controlled trial. Aust J Physiother. 2007;53(3):163-9. doi: 10.1016/s0004-9514(07)70023-5.
- Kasim I, Gulyas M, Almgren B, Hogman M. A recruitment breath manoeuvre directly after endotracheal suction improves lung function: an experimental study in pigs. Ups J Med Sci. 2009;114(3):129-35. doi: 10.1080/03009730903177357.
- Jesus AC, Figueiredo AM, Cordeiro ALL. Recruitment maneuvers in patients with acute respiratory distress syndrome: a systematic review and metanalysis. Einstein (Sao Paulo). 2024 Dec 16;22:eRW0372. doi: 10.31744/einstein_journal/2024RW0372. eCollection 2024.
- Blakeman TC, Scott JB, Yoder MA, Capellari E, Strickland SL. AARC Clinical Practice Guidelines: Artificial Airway Suctioning. Respir Care. 2022 Feb;67(2):258-271. doi: 10.4187/respcare.09548.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-CHITS-013
- 2025-A01845-44 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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