Back to resultsEffects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation
Primary Purpose
Deflating Method
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tracheal tube cuffs differ in deflation
Sponsored by
About this trial
This is an interventional prevention trial for Deflating Method focused on measuring Deflating method, Extubation phase, Coughing reaction
Eligibility Criteria
Inclusion Criteria: Elective endotracheal intubation under general anesthesia. Operation time < 3 h. ASA grade I or II. Age 18~65 years old. Exclusion Criteria: 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.
Sites / Locations
- the Affiliated Hospital of Yangzhou University, Yangzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Slowly and evenly draw the gas in the cuff
One-time aspiration of tracheal catheter cuff gas
Arm Description
Outcomes
Primary Outcome Measures
Grading of cough reaction
Grading of cough reactions
Change in Blood pressure
Hemodynamics
Change in Heart rate
Hemodynamics
Secondary Outcome Measures
Adverse reactions
Hypoventilation, pharyngeal discomfort, hoarseness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05647395
Brief Title
Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation
Official Title
Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhuan Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deflating Method
Keywords
Deflating method, Extubation phase, Coughing reaction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Slowly and evenly draw the gas in the cuff
Arm Type
Experimental
Arm Title
One-time aspiration of tracheal catheter cuff gas
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Tracheal tube cuffs differ in deflation
Intervention Description
When removing the endotracheal tube, the gas in the cuff is drawn at a uniform and slow pace
Primary Outcome Measure Information:
Title
Grading of cough reaction
Description
Grading of cough reactions
Time Frame
During extubation procedure
Title
Change in Blood pressure
Description
Hemodynamics
Time Frame
Preoperatively, immediately before extubation, immediately after extubation, 1 minute after extubation, 3 minutes after extubation, 10 minutes after extubation
Title
Change in Heart rate
Description
Hemodynamics
Time Frame
Preoperatively, immediately before extubation, immediately after extubation, 1 minute after extubation, 3 minutes after extubation, 10 minutes after extubation
Secondary Outcome Measure Information:
Title
Adverse reactions
Description
Hypoventilation, pharyngeal discomfort, hoarseness
Time Frame
Within 24 hours after removal of the endotracheal tube
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective endotracheal intubation under general anesthesia.
Operation time < 3 h.
ASA grade I or II.
Age 18~65 years old.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan Zhang
Phone
+8615062791355
Email
zhangzhuancg@163.com
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University, Yangzhou University
City
Yangzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Zhang, professor
Phone
+8615062791355
Ext
+8615062791355
Email
zhangzhuancg@163.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation
We'll reach out to this number within 24 hrs