Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients

Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients, a Randomized Controlled Trial.

This is a randomized controlled trial compared two methods to drainage subglottic secretion in prolonged intubated patients.After enrolled, patients are randomized assigned to intermittent subglottic secretion drainage group and air-impingement manipulation group.

Study Overview

• Status: Unknown
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Procedure: Manual air-impingement operation; Device: subglottic secretion drainage

Detailed Description

Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic space is a well-proven cause of VAP. Therefore, prevention should include the aspiration of secretions from the subglottic space. Investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. This method has been granted as a patent by Chinese national intellectual property patent office, it has been used in investigators' daily work for more than 10 years and more than 20 Chinese ICUs have used it everyday. Investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Li, Master; Phone Number: 86-13552976483; Email: lijie8497@hotmail.com
• Study Contact Backup: Name: Sun Bing; Phone Number: 86-13911151075; Email: ricusunbing@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing Chaoyang Hospital
      • Contact: Jie Li, Master; Phone Number: 86-13552976483; Email: cyhrt@sina.cn
      • Contact: Bing Sun, Doctor; Phone Number: 86-13911151075; Email: ricusunbing@gmail.com
      • Principal Investigator: Jie Li, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Should meet all the criteria:

1. Intubation less than 24 hours before admitting respiratory intensive care unit;
2. Anticipated intubation for more than 72 hours;
3. Anticipated survival time is more than 2 weeks

Exclusion Criteria:

Meet any of these criteria:

1. PEEP≥10cmH2O or FiO2≥0.8;
2. unstable hemodynamics;
3. severe bulla and pneumothorax;
4. enrolled in other study;
5. cuff leak test is positive.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual air-impingement operation; A method which we invented to clear subglottic secretion	Device: subglottic secretion drainage; The conventional method with a special tube to drainage subglottic secretion
Active Comparator: subglottic secretion drainage; The conventional method with a special tube to drainage subglottic secretion	Procedure: Manual air-impingement operation; A method which we invented to clear subglottic secretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with ventilator-associated pneumonia	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU mortality	Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Invasive ventilation duration	Participants will be followed for the duration of invasive ventilation, an expected average of 7-10 days

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Principal Investigator: Jie Li, Master, Beijing Chao Yang Hospital

Publications and helpful links

General Publications

• Li Y, Yuan X, Sun B, Li HC, Chu HW, Wang L, Zhao Y, Tang X, Wang R, Li XY, Tong ZH, Wang C. Rapid-flow expulsion maneuver in subglottic secretion clearance to prevent ventilator-associated pneumonia: a randomized controlled study. Ann Intensive Care. 2021 Jun 24;11(1):98. doi: 10.1186/s13613-021-00887-5.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: ventilator associated pneumonia; manual air-impingement operation; subglottic secretion drainage; prolonged intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: BJCYHRT-001