Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications
Primary Purpose
Intubation Complication
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ventilation with critical intracuff pressure (Pcr)
ventilation with critical intracuff pressure (Pcr)
Sponsored by
About this trial
This is an interventional supportive care trial for Intubation Complication focused on measuring anesthesia, endotracheal tube cuff pressure
Eligibility Criteria
Inclusion Criteria:
- Elective Surgery under general anesthesia requiring endotracheal tube with mechanical ventilation and expected anesthesia duration of at least 2 hours.
- No contra-indication for intra-operative volume controlled mechanical ventilation
- Flat supine surgeries without expected positional adjustments
- American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria:
- Use of Nitrous Oxide
- BMI > 40
- Ventilation through Nasal intubation or Tracheostomy
- Preexisting sore throat, coughing, nausea/vomiting
- Recent history of upper respiratory infection
- Pregnancy
- Expected to be kept intubated after surgery completion
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Minimum intracuff pressure at which there is no air leak around the cuff.
Secondary Outcome Measures
Number of patients with postoperative sore throat as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative sore throat as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative sore throat as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative coughing as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative coughing as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative coughing as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative aspiration as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative aspiration as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Number of patients with postoperative aspiration as measured by a standardized questionnaire
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Full Information
NCT ID
NCT04302142
First Posted
March 6, 2020
Last Updated
August 26, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04302142
Brief Title
Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications
Official Title
Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications: Prospective Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped due to COVID restrictions on staff, therefore enrollment was not started.
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Complication
Keywords
anesthesia, endotracheal tube cuff pressure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
ventilation with critical intracuff pressure (Pcr)
Intervention Description
Once the intra-cuff pressure is measured and recorded, the cuff will be deflated by drawing the air 0.5ml per step with each step lasting 3 breaths until a leak, in which a 10% reduction in expiratory volume over the inspiratory tidal volume, is detected.Cuff will then be reinflated until the expiratory tidal volume reaches the inspiratory tidal volume and the discrepancy between the inspiratory and expiratory tidal volume is less than 10 percent. If the intra-cuff pressure applied by the anesthesia care team is inadequate and the discrepancy between the inspiratory and expiratory tidal volume is 10% or greater, the cuff will be further inflated with air 0.5ml per step with each step lasting 3 breaths until it reaches Pcr. This Pcr will be maintained during the entire anesthesia time until extubation.During the course of surgery, if any leak is detected, the cuff will be re-inflated by 0.5ml of air until the leak is not detectable.
Intervention Type
Device
Intervention Name(s)
ventilation with critical intracuff pressure (Pcr)
Intervention Description
Pcr is obtained just as it is done in the intervention group. The cuff will then be reinsufflated to the actual cuff pressure the care team initially chose. The care team will be blinded to the measured critical cuff pressures and hence will maintain the usual level of intracuff pressure in the control group during the entire anesthesia time.
Primary Outcome Measure Information:
Title
Minimum intracuff pressure at which there is no air leak around the cuff.
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
30 minutes post extubation
Title
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
2 hours post extubation
Title
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
24 hours post extubation
Title
Number of patients with postoperative coughing as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
30 minutes post extubation
Title
Number of patients with postoperative coughing as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
2 hours post extubation
Title
Number of patients with postoperative coughing as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
24 hours post extubation
Title
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
30 minutes post extubation
Title
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
2 hours post extubation
Title
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
24 hours post extubation
Title
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
30 minutes post extubation
Title
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
2 hours post extubation
Title
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Description
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
Time Frame
24 hours post extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective Surgery under general anesthesia requiring endotracheal tube with mechanical ventilation and expected anesthesia duration of at least 2 hours.
No contra-indication for intra-operative volume controlled mechanical ventilation
Flat supine surgeries without expected positional adjustments
American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria:
Use of Nitrous Oxide
BMI > 40
Ventilation through Nasal intubation or Tracheostomy
Preexisting sore throat, coughing, nausea/vomiting
Recent history of upper respiratory infection
Pregnancy
Expected to be kept intubated after surgery completion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yandong Jiang, MD,PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications
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