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

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.

Study Overview

• Status: Recruiting
• Conditions: Deflating Method
• Intervention / Treatment: Behavioral: Tracheal tube cuffs differ in deflation

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhuan Zhang; Phone Number: +8615062791355; Email: zhangzhuancg@163.com

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • Recruiting
      • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions	Hypoventilation, pharyngeal discomfort, hoarseness	Within 24 hours after removal of the endotracheal tube

Collaborators and Investigators

• Sponsor: Zhuan Zhang

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Deflating method; Extubation phase; Coughing reaction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 20221121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No