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NCT Number: NCT06867237

The Effect of Continuous Management of Suction Cuff Pressure and Subglottic Irrigation Suction on Preventing VALRI Study

Assessing the effectiveness of continuous cuff pressure management combined with subglottic suction irrigation in reducing ventilator-associated lower respiratory tract infections (VALRTI) in mechanically ventilated patients at high risk of aspiration.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years;
  • Undergoing endotracheal intubation or tracheostomy;
  • Expected duration of mechanical ventilation exceeding 72 hours;
  • Presence of one or more high-risk factors for reflux/aspiration: recurrent laryngeal nerve injury, cerebral infarction/cerebral hemorrhage (new or pre-existing swallowing dysfunction), cranial surgery/traumatic brain injury (TBI), neuromuscular junction disorders (e.g., myasthenia gravis, muscular dystrophy, Parkinson's disease, or other conditions that weaken swallowing muscle strength and coordination), continuous use of muscle relaxants for ≥ 48 hours during mechanical ventilation, ICU-acquired myopathy, ICU-acquired weakness, gastroparesis (gastric residual volume > 500 mL/6 hours), or impaired consciousness;
  • Voluntary participation in the study by the subject or their legal representative, with signed informed consent.

Exclusion criteria

  • Expected duration of mechanical ventilation less than 48 hours;
  • Pregnant or breastfeeding women;
  • Patients with tracheoesophageal or bronchopleural fistula;
  • Difficult intubation (more than three attempts) or patients with reflux/aspiration during intubation (with lung injury and secondary pulmonary infection);
  • Patients with irreversible disease, end-stage conditions, or those expected to die in the near future;
  • Patients already diagnosed with ventilator-associated pneumonia (VAP), i.e., excluding hospital-acquired pneumonia;
  • Patients participating in other clinical trials that are expected to influence the results of this study;
  • Patients deemed unsuitable for inclusion in the study by the investigator.

Treatment and study plan

Suction cuff pressure

Device

Use the device to do continuous management of suction cuff pressure and subglottic irrigation suction

Other names: airway management

Primary outcomes

  1. The number of days free from VALRTI within 28 days.

    Time frame: 28 days

    The number of days free from ventilator-associated lower respiratory tract infection (VALRTI) within 28 days.

Study contacts

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

Yanni Zhang, dr.

CONTACT

[email protected]

13381819621

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

The Effect of Continuous Management of Suction Cuff Pressure and Subglottic Irrigation Suction on the Outcomes of Mechanically Ventilated Patients With High Risk of Aspiration: a Single-center, Prospective, Randomized Controlled Trial

Acronym: SCOPE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 10, 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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