CClinicalTrials.gg
Status unknownNCT03871985Updated Mar 12, 2019

Efficacy of Two Intermittent Subglottic Secretion

An interventional study of Subglottic secretion lavage combined with aspiration and Subglottic secretion aspiration in Ventilator Associated Pneumonia, sponsored by The First Hospital of Jilin University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-12.

Sponsored by The First Hospital of Jilin University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease

Read the detailed description

Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation. Many studies have shown that the accumulation of subglottic secretions above the endotracheal cuff plays an important role in the pathogenesis of VAP. Subglottic secretion drainage (SSD) has been shown to be associated with a lower incidence of VAP in previous meta-analyses. Most studies in past reported that in the group of patients in whom endotracheal tube (ETT) was used and subglottic secretion drainage was applied compared to the group without subglottic secretion drainage.Very few studies compared two different methods of SSD,such as subglottic secretion lavage combined with aspiration or pure aspiration.The tubes need frequent cleaning as they often get blocked, especially the draining duct. This may be the reason why they are not commonly applied. However,subglottic secretion lavage combined with aspiration can reduce the incidence of tube blockage.So The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease.

02

Conditions studied

  • Ventilator Associated Pneumonia

Keywords

  • ventilator-associated pneumonia
  • subglottic secretion drainage
  • endotracheal tube
  • length of mechanical ventilation
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 234 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
234 participants (estimated)

Study arms

  • Experimental
    Lavage combined with aspiration

    Intermittent subglottic secretions lavage combined with aspiration

    Procedure: Subglottic secretion lavage combined with aspiration

  • Active comparator
    Pure aspiration

    Intermittent subglottic secretions aspiration

    Procedure: Subglottic secretion aspiration

Interventions

  • ProcedureSubglottic secretion lavage combined with aspiration

    Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion lavage combined with aspiration was performed every 4 hours: Underwent preoxygenation before cuff pressure checking, and was maintained between 30 and 35 cmH2O. After aspirating secretions from the mouth, nose, and airway, 2-5 mL distilled sterile water was instilled through the subglottic lumen, and then the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat lavage and aspiration until the irrigation fluid is clear. After washing, cuff pressure checking and was maintained between 25 and 30 cmH2O.

  • ProcedureSubglottic secretion aspiration

    Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion aspiration was performed every 4 hours:Underwent preoxygenation before cuff pressure checking ,and was maintained between 25 and 30 cmH2O. After aspirating secretions from the mouth, nose, and airway, the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat suction until the secretion is completely absorbed.

06

What researchers measure

Primary outcomes

  1. Incidence of ventilator-associated pneumonia

    is pneumonia that occurs when an artificial airway is established and mechanically ventilated

    Time frame: through study completion, an average of 10 months

Secondary outcomes

  1. Incidence of draining duct blockage

    If mucus flow stopped during subglottic suctioning with a sudden increase of the negative pressure in the proximal port of the suction suggesting a probable occlusion

    Time frame: through study completion, an average of 10 months

Other outcomes

  1. length of mechanical ventilation

    length of mechanical ventilation

    Time frame: through study completion, an average of 10 months

  2. The coincidence rate between pathogens of subglottic secretions and the lower respiratory tract

    The coincidence rate between pathogens of subglottic secretions and the lower respiratory tract

    Time frame: through study completion, an average of 10 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03871985
Lead sponsor
The First Hospital of Jilin University
Responsible party
Sponsor
First posted
Mar 12, 2019
Start date
Mar 15, 2019 (estimated)
Primary completion
Dec 30, 2019 (estimated)
Completion
Jan 15, 2020 (estimated)
Last update
Mar 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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