Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation
1 other identifier
interventional
90
1 country
1
Brief Summary
Patients with endotracheal intubation and general anesthesia often have severe choking and hemodynamic fluctuations during the extubation period, which increases the risk of cerebrovascular accident, arrhythmia, incision bleeding and so on . This study aimed to observe the effects of different methods of deflating of endotracheal tube cuffs on cough response and hemodynamics during periextubation in patients undergoing general anesthesia surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
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
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2024
CompletedDecember 12, 2022
December 1, 2022
10 months
November 21, 2022
December 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Grading of cough reaction
Grading of cough reactions
During extubation procedure
Change in Blood pressure
Hemodynamics
Preoperatively, immediately before extubation, immediately after extubation, 1 minute after extubation, 3 minutes after extubation, 10 minutes after extubation
Change in Heart rate
Hemodynamics
Preoperatively, immediately before extubation, immediately after extubation, 1 minute after extubation, 3 minutes after extubation, 10 minutes after extubation
Secondary Outcomes (1)
Adverse reactions
Within 24 hours after removal of the endotracheal tube
Study Arms (2)
Slowly and evenly draw the gas in the cuff
EXPERIMENTALOne-time aspiration of tracheal catheter cuff gas
NO INTERVENTIONInterventions
When removing the endotracheal tube, the gas in the cuff is drawn at a uniform and slow pace
Eligibility Criteria
You may qualify if:
- Elective endotracheal intubation under general anesthesia.
- Operation time \< 3 h.
- ASA grade I or II.
- Age 18\~65 years old.
You may not qualify if:
- Throat and neck surgery.
- Those assessed to have a high risk of reflux aspiration.
- Difficulty intubation.
- History of snoring before surgery.
- Recent respiratory illness such as chronic cough.
- Previous airway hyperresponsiveness, such as asthma.
- recent use of cough suppressants.
- Patients with severe heart, liver and kidney diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhuan Zhanglead
Study Sites (1)
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu, China
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
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 12, 2022
Study Start
October 1, 2022
Primary Completion
July 30, 2023
Study Completion
July 30, 2024
Last Updated
December 12, 2022
Record last verified: 2022-12