Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation

• Sponsor: Zhuan Zhang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05647395
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.9
• Patients Per Site Per Month: 4.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Deflating Method	Behavioral: Tracheal tube cuffs differ in deflation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Slowly and evenly draw the gas in the cuff	Behavioral: Tracheal tube cuffs differ in deflation; When removing the endotracheal tube, the gas in the cuff is drawn at a uniform and slow pace
No Intervention: One-time aspiration of tracheal catheter cuff gas

Outcome Measures

Primary Outcome Measures

1. Grading of cough reaction [During extubation procedure]

   Grading of cough reactions

2. Change in Blood pressure [Preoperatively, immediately before extubation, immediately after extubation, 1 minute after extubation, 3 minutes after extubation, 10 minutes after extubation]

   Hemodynamics

3. Change in Heart rate [Preoperatively, immediately before extubation, immediately after extubation, 1 minute after extubation, 3 minutes after extubation, 10 minutes after extubation]

   Hemodynamics

Secondary Outcome Measures

1. Adverse reactions [Within 24 hours after removal of the endotracheal tube]

   Hypoventilation, pharyngeal discomfort, hoarseness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Elective endotracheal intubation under general anesthesia.

2. Operation time < 3 h.

3. ASA grade I or II.

4. Age 18~65 years old.

Exclusion Criteria:

1. Throat and neck surgery.

2. Those assessed to have a high risk of reflux aspiration.

3. Difficulty intubation.

4. History of snoring before surgery.

5. Recent respiratory illness such as chronic cough.

6. Previous airway hyperresponsiveness, such as asthma.

7. recent use of cough suppressants.

8. Patients with severe heart, liver and kidney diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu	China

Sponsors and Collaborators

• Zhuan Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhuan Zhang, Principal Investigator, Yangzhou University
• ClinicalTrials.gov Identifier: NCT05647395
• Other Study ID Numbers: 20221121
• First Posted: Dec 12, 2022
• Last Update Posted: Dec 12, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhuan Zhang, Principal Investigator, Yangzhou University: Deflating method; Extubation phase; Coughing reaction
• Additional relevant MeSH terms: Cough

Study Results

No Results Posted as of Dec 12, 2022