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出境医 / 临床实验 / Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia
Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia
Study Description
Brief Summary:
Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The authors thought that the pressure in the cuff could be changed during the operation due to various factors and that the pressure in the cuff should be monitored continuously. In this study, the investigators will monitor the cuff pressure during anesthesia and analyze the factors affecting the cuff pressure.
| Condition or disease | Intervention/treatment |
|---|---|
| Intubation, Intratracheal | Other: monitoring of the endotracheal tube cuff |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 201 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia |
| Actual Study Start Date : | April 28, 2020 |
| Actual Primary Completion Date : | November 4, 2020 |
| Actual Study Completion Date : | November 4, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
endotracheal intubation under general anesthesia
Adults who require endotracheal intubation for head and neck surgery under general anesthesia
|
Other: monitoring of the endotracheal tube cuff
We will enroll adult patients who will undergo endotracheal intubation for general anesthesia of head and neck surgery. The cuff pressure of the endotracheal tube will be monitored continuously during anesthesia. The cuff pressure value will be recorded and analyzed after completing the study.
|
Outcome Measures
Primary Outcome Measures :
- Changes of cuff pressure during anesthesia [ Time Frame: participants will followed until post-operative 1 day. ]The investigators will monitor the pressure of the endotracheal tube cuff during anesthesia. The changes of the cuff pressure from the baseline value will be monitored continuously.
Eligibility Criteria
| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Adults who require endotracheal intubation for head and neck surgery under general anesthesia
Criteria
Inclusion Criteria:
- 1. Adults who require endotracheal intubation for head and neck surgery under general anesthesia
Exclusion Criteria:
- 1. Patients under 20 years old
- 2. Patients who should undergo tracheostomy
- 3. Patients who need to use an endotracheal tube without a cuff
- 4. Pregnant women
- 5. Patients who can not read the consent form or are not fluent in Korean
- 6. Patients who refused the clinical trial
Contacts and Locations
Locations
| Korea, Republic of | |
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | |
| Seoul, Korea, Republic of, 03722 | |
Sponsors and Collaborators
Yonsei University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 3, 2019 | ||||
| First Posted Date | May 6, 2019 | ||||
| Last Update Posted Date | June 1, 2021 | ||||
| Actual Study Start Date | April 28, 2020 | ||||
| Actual Primary Completion Date | November 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Changes of cuff pressure during anesthesia [ Time Frame: participants will followed until post-operative 1 day. ] The investigators will monitor the pressure of the endotracheal tube cuff during anesthesia. The changes of the cuff pressure from the baseline value will be monitored continuously.
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia | ||||
| Official Title | Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia | ||||
| Brief Summary | Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The authors thought that the pressure in the cuff could be changed during the operation due to various factors and that the pressure in the cuff should be monitored continuously. In this study, the investigators will monitor the cuff pressure during anesthesia and analyze the factors affecting the cuff pressure. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Adults who require endotracheal intubation for head and neck surgery under general anesthesia | ||||
| Condition | Intubation, Intratracheal | ||||
| Intervention | Other: monitoring of the endotracheal tube cuff
We will enroll adult patients who will undergo endotracheal intubation for general anesthesia of head and neck surgery. The cuff pressure of the endotracheal tube will be monitored continuously during anesthesia. The cuff pressure value will be recorded and analyzed after completing the study.
|
||||
| Study Groups/Cohorts | endotracheal intubation under general anesthesia
Adults who require endotracheal intubation for head and neck surgery under general anesthesia
Intervention: Other: monitoring of the endotracheal tube cuff
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
201 | ||||
| Original Estimated Enrollment |
200 | ||||
| Actual Study Completion Date | November 4, 2020 | ||||
| Actual Primary Completion Date | November 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 20 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03938493 | ||||
| Other Study ID Numbers | 4-2019-0100 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Yonsei University | ||||
| Study Sponsor | Yonsei University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Yonsei University | ||||
| Verification Date | May 2021 | ||||
