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

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

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • VAR
      • Toulon, VAR, France, 83000
        • Recruiting
        • Hôpital National d'Instruction des Armées Sainte-Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cyril PERNOD, MD, Hôpital National d'Instruction des Armées (HNIA) Sainte-Anne, Toulon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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