NCT07358039

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

January 14, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Endotracheal suctionAlveolar recruitmentElectrical impedance tomographyEnd-expiratory lung volumeIntensive careMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Percentage change in end-expiratory lung volume (EELV) after suctioning

    EELV assessed by end-expiratory lung impedance measured with electrical impedance tomography (PulmoVista® V500).

    15 minutes after endotracheal suctioning

Secondary Outcomes (3)

  • Change in lung compliance

    Baseline and 15 minutes after suctioning

  • Change in functional residual capacity (FRC)

    Baseline and 15 minutes after suctioning

  • Change in PaO₂/FiO₂ ratio

    Baseline and 15 minutes after suctioning

Study Arms (2)

A

EXPERIMENTAL

Patients undergo closed-circuit endotracheal suctioning without a recruitment maneuver.

Procedure: Closed-circuit endotracheal suctioning

B

EXPERIMENTAL

Patients undergo closed-circuit endotracheal suctioning immediately followed by a recruitment maneuver.

Procedure: Suction + Recruitment maneuver

Interventions

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.

B

Standard closed-circuit endotracheal suctioning performed for less than 15 seconds without disconnecting the ventilator.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥18 years
  • Covered by national health insurance
  • Admitted to the intensive care unit
  • Intubated and mechanically ventilated
  • Written informed consent obtained from a legally authorized representative or next of kin

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital National d'Instruction des Armées Sainte-Anne

Toulon, VAR, 83000, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 17725473BACKGROUND
  • 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.

    PMID: 19736601BACKGROUND
  • 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.

    PMID: 39699411BACKGROUND
  • 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.

    PMID: 35078900BACKGROUND

MeSH Terms

Interventions

Suction

Intervention Hierarchy (Ancestors)

DrainageSurgical Procedures, Operative

Study Officials

  • Cyril PERNOD, MD

    Hôpital National d'Instruction des Armées (HNIA) Sainte-Anne, Toulon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

April 2, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations