- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302142
Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications
August 26, 2022 updated by: Yandong Jiang, The University of Texas Health Science Center, Houston
Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications: Prospective Randomized Control Trial
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control Group
|
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.
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.
|
EXPERIMENTAL: Intervention group
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Minimum intracuff pressure at which there is no air leak around the cuff.
Time Frame: during surgery
|
during surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Time Frame: 30 minutes post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
30 minutes post extubation
|
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Time Frame: 2 hours post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
2 hours post extubation
|
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Time Frame: 24 hours post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
24 hours post extubation
|
Number of patients with postoperative coughing as measured by a standardized questionnaire
Time Frame: 30 minutes post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
30 minutes post extubation
|
Number of patients with postoperative coughing as measured by a standardized questionnaire
Time Frame: 2 hours post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
2 hours post extubation
|
Number of patients with postoperative coughing as measured by a standardized questionnaire
Time Frame: 24 hours post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
24 hours post extubation
|
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Time Frame: 30 minutes post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
30 minutes post extubation
|
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Time Frame: 2 hours post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
2 hours post extubation
|
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Time Frame: 24 hours post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
24 hours post extubation
|
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Time Frame: 30 minutes post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
30 minutes post extubation
|
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Time Frame: 2 hours post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
2 hours post extubation
|
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Time Frame: 24 hours post extubation
|
The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe
|
24 hours post extubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yandong Jiang, MD,PhD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2021
Primary Completion (ANTICIPATED)
June 1, 2021
Study Completion (ANTICIPATED)
June 1, 2021
Study Registration Dates
First Submitted
March 6, 2020
First Submitted That Met QC Criteria
March 9, 2020
First Posted (ACTUAL)
March 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-20-0018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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