Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients
1 other identifier
interventional
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 15, 2014
August 1, 2014
2.3 years
December 30, 2013
August 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with ventilator-associated pneumonia
Up to 28 days
Secondary Outcomes (1)
ICU mortality
Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
Other Outcomes (1)
Invasive ventilation duration
Participants will be followed for the duration of invasive ventilation, an expected average of 7-10 days
Study Arms (2)
subglottic secretion drainage
ACTIVE COMPARATORThe conventional method with a special tube to drainage subglottic secretion
Manual air-impingement operation
EXPERIMENTALA method which we invented to clear subglottic secretion
Interventions
A method which we invented to clear subglottic secretion
The conventional method with a special tube to drainage subglottic secretion
Eligibility Criteria
You may qualify if:
- Should meet all the criteria:
- Intubation less than 24 hours before admitting respiratory intensive care unit;
- Anticipated intubation for more than 72 hours;
- Anticipated survival time is more than 2 weeks
You may not qualify if:
- Meet any of these criteria:
- PEEP≥10cmH2O or FiO2≥0.8;
- unstable hemodynamics;
- severe bulla and pneumothorax;
- enrolled in other study;
- cuff leak test is positive.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Chaoyang hospital
Beijing, Beijing Municipality, 100020, China
Related Publications (1)
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.
PMID: 34165661DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Li, Master
Beijing Chao Yang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RRT-NPS
Study Record Dates
First Submitted
December 30, 2013
First Posted
January 10, 2014
Study Start
February 1, 2014
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
August 15, 2014
Record last verified: 2014-08