Efficacy of Two Intermittent Subglottic Secretion

Ventilator Associated Pneumonia Clinical Trial

Official title:

Efficacy of Intermittent Subglottic Secretion Lavage Combined With Aspiration Preventing Ventilator Associated Pneumonia in Patients With Severe Neurological Disease：A Single-center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03871985
• Other study ID #: SSD-SSLACA
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: December 2018
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 234
• Est. completion date: January 15, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Procedure:
• Subglottic 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.
• Subglottic 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of mechanical ventilation	length of mechanical ventilation	through study completion, an average of 10 months
Other	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	through study completion, an average of 10 months
Primary	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	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	through study completion, an average of 10 months