Efficacy of Two Intermittent Subglottic Secretion

NCT03871985 | Unknown

• 1 other identifier: SSD-SSLACA
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Ventilator Associated Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of ventilator-associated pneumonia

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

  through study completion, an average of 10 months

Secondary Outcomes (1)

• Incidence of draining duct blockage

  through study completion, an average of 10 months

Other Outcomes (2)

• length of mechanical ventilation

  through study completion, an average of 10 months

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

  through study completion, an average of 10 months

Study Arms (2)

Lavage combined with aspiration

EXPERIMENTAL

Intermittent subglottic secretions lavage combined with aspiration

Procedure: Subglottic secretion lavage combined with aspiration

Pure aspiration

ACTIVE COMPARATOR

Intermittent subglottic secretions aspiration

Procedure: Subglottic secretion aspiration

Interventions

Subglottic secretion lavage combined with aspiration PROCEDURE

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.

Lavage combined with aspiration

Subglottic secretion aspiration PROCEDURE

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.

Pure aspiration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 12, 2019
• Study Start: March 15, 2019
• Primary Completion: December 30, 2019
• Study Completion: January 15, 2020
• Last Updated: March 12, 2019

Record last verified: 2018-12