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NCT Number: NCT07130123

Endotracheal Suctionning During Positive Pressure Extubation in ICU

The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.

Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire d'Orléans

Orléans, Loiret, 45067, France

Location status: Recruiting

Location contact

Cécile FOSSAT

CONTACT

[email protected]

+33238575252

About this study

This is a prospective, randomised, controlled trial. The aim of this study is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.

Inclusion : Participants who meet eligibility criteria will be randomized into experimental arm (endotracheal suctioning during positive pressure extubation) or control arm (no endotracheal suction during positive pressure extubation).

Intervention and Follow-up : participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.

End of study : at the end of the study visit (28 days after extubation), vital status of participants will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient
  • Intubated for more than 48 hours
  • Patient for whom extubation is prescribed by the patient's physician

Exclusion criteria

  • Headboard restriction>30°.
  • Decision to limit active treatment in advance of reintubation
  • Protected person (under guardianship or curatorship)
  • Person under court protection
  • Persons deprived of liberty
  • Persons not affiliated to a social security scheme
  • Pregnant or breast-feeding woman
  • No co-inclusion with a study whose period of interest is follow-up within 3 hours of extubation.

Treatment and study plan

Suctionning extubation

Procedure

We will remove the intubation tube with endotracheal suctioning during the extubation procedure and maintain positive end expiratory pressure (PEEP) and pressure support. The PEEP level will be 10 cmH2O and the pressure support 7 cmH2O for 2 minutes prior to extubation. The vacuum level will be the maximum level (standard procedure in the unit), i.e. 450 mmHg. The closed-system suction probe is inserted up to the last mark corresponding to 40cm. The size of our closed system is identical for all patients, i.e. 14 french.

No suctionning Extubation

Procedure

In the control group, removal of the intubation tube during the extubation procedure is performed with PEEP maintained, without endotracheal suctioning. The PEEP level will be set at 10 cmH2O and the pressure at 7 cmH2O in the 2 minutes prior to extubation.

Primary outcomes

  1. Respiratoy/oxygenation index (ROX index)

    Time frame: 3 hours after extubation

    Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment)

Secondary outcomes

  1. Mechanical ventilation weaning failure

    Time frame: During 7 days after extubation

    Weaning failure corresponds with death or new intabution

  2. ROX index evolution

    Time frame: During 3 hours after extubation

    Rox index will be assessed 3 times after extubation in order to evaluate its evolution (blind assessment) :

    • 30 minutes after extubation
    • 1 hour after extubation
    • 3 hour after extubation
  3. Pneumonia after extubation

    Time frame: During 7 days after extubation

    Rate of hospital-acquired pneumonia confirmed by an investigator

  4. Airway clearance technique

    Time frame: During 24 hours after extubation

    Use of any airway clearance technique after extubation :

    • nasotracheal suction
    • respiratory physiotherapy
    • bronchial fibroscopy

Study contacts

Contact information is provided by the study sponsor or research team.

Cécile FOSSAT

CONTACT

[email protected]

+33238575252

Fanny LOUAT

CONTACT

[email protected]

+33238744295

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Removal of the Intubation Tube Under Positive Pressure With or Without Endotracheal Suctioning During Extubation in Intensive Care: a Prospective Randomised Controlled Trial

Acronym: INTENTION

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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