Intubation ComplicationNCT04302142
Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications
A study testing ventilation with critical intracuff pressure (Pcr) in people with Intubation Complication, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- ventilation with critical intracuff pressure (Pcr)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2021to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Intubation Complication
- Being tested
- ventilation with critical intracuff pressure (Pcr)
- Keywords
- anesthesia, endotracheal tube cuff pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilation with critical intracuff pressure (Pcr)Device
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.
ventilation with critical intracuff pressure (Pcr)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Device: ventilation with critical intracuff pressure (Pcr) |
| Control Group | Placebo comparator | Not described Receives: Device: ventilation with critical intracuff pressure (Pcr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum intracuff pressure at which there is no air leak around the cuff.
Measured: during surgery
Secondary outcomes (12)
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
Measured: 30 minutes post extubation
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
Measured: 2 hours post extubation
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
Measured: 24 hours post extubation
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
Measured: 30 minutes post extubation
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
Measured: 2 hours post extubation
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
Measured: 24 hours post extubation
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
Measured: 30 minutes post extubation
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
Measured: 2 hours post extubation
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
Measured: 24 hours post extubation
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
Measured: 30 minutes post extubation
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
Measured: 2 hours post extubation
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
Measured: 24 hours post extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study startJun 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: The study was stopped due to COVID restrictions on staff, therefore enrollment was not started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yandong Jiang, The University of Texas Health Science Center, Houston
- Investigators
- Yandong Jiang, MD,PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302142
- Sponsor's protocol ID
- HSC-MS-20-0018
- Status last verified
- Aug 2022
- First submitted
- 6 Mar 2020
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications: Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04302142
- Acronym / sponsor ID
- HSC-MS-20-0018
- Conditions
- Intubation Complication
- Keywords
- anesthesia, endotracheal tube cuff pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to COVID restrictions on staff, therefore enrollment was not started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: ventilation with critical intracuff pressure (Pcr) |
| Control Group | Placebo comparator | Device: ventilation with critical intracuff pressure (Pcr) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Use of Nitrous Oxide
- BMI > 40
- Ventilation through Nasal intubation or Tracheostomy
- Preexisting sore throat, coughing, nausea/vomiting
- Recent history of upper respiratory infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilation with critical intracuff pressure (Pcr)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. | Device | Intervention group |
| ventilation with critical intracuff pressure (Pcr)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. | Device | Control Group |
Primary outcome
Minimum intracuff pressure at which there is no air leak around the cuff.
Time frame: during surgery
12 secondary outcomes
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Time frame: 30 minutes post extubation
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Time frame: 2 hours post extubation
Number of patients with postoperative sore throat as measured by a standardized questionnaire
Time frame: 24 hours post extubation
Number of patients with postoperative coughing as measured by a standardized questionnaire
Time frame: 30 minutes post extubation
Number of patients with postoperative coughing as measured by a standardized questionnaire
Time frame: 2 hours post extubation
Number of patients with postoperative coughing as measured by a standardized questionnaire
Time frame: 24 hours post extubation
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Time frame: 30 minutes post extubation
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Time frame: 2 hours post extubation
Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
Time frame: 24 hours post extubation
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Time frame: 30 minutes post extubation
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Time frame: 2 hours post extubation
Number of patients with postoperative aspiration as measured by a standardized questionnaire
Time frame: 24 hours post extubation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yandong Jiang, MD,PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilation with critical intracuff pressure (Pcr) in people with Intubation Complication, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum intracuff pressure at which there is no air leak around the cuff. (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.