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出境医 / 临床实验 / The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes
The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes
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 common method to inflate the endotracheal tube cuff is palpation method. However, the palpation of the cuff is not accurate because of the different size between the pilot balloon and the cuff. Thus, the investigators hypothesized that the different size of the tube will affect the accuracy of the palpation method.
| Condition or disease | Intervention/treatment |
|---|---|
| Intubation, Intratracheal | Other: cuff pressure of the endotracheal tube |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 208 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes |
| Estimated Study Start Date : | November 2019 |
| Estimated Primary Completion Date : | May 2020 |
| Estimated Study Completion Date : | June 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
intubation using the endotracheal tube size of 6.0 or 8.0
Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
|
Other: cuff pressure of the endotracheal tube
The endotracheal intubation will be performed after the anesthetic induction. The cuff will be inflated using the air by the palpation method. The cuff pressure of the endotracheal tube will be measured using the manometer.
|
Outcome Measures
Primary Outcome Measures :
- The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range. [ Time Frame: participants will followed until the completion of the anesthetic induction (less than 15 minutes). ]the investigator will monitor the pressure of the endotracheal tube cuff after anesthetic induction.
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
Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
Criteria
Inclusion Criteria:
- 1. Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
Exclusion Criteria:
- 1. Patients under 20 years old
- 2. Patients receiving emergency surgery
- 3. Patients with tracheostomy tubes
- 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
- 7. Patient with endotracheal mass in the trachea where the cuff is located
- 8. Tracheal deviation is observed in the neck due to tumor in the neck
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 | May 9, 2019 | ||||
| Estimated Study Start Date | November 2019 | ||||
| Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range. [ Time Frame: participants will followed until the completion of the anesthetic induction (less than 15 minutes). ] the investigator will monitor the pressure of the endotracheal tube cuff after anesthetic induction.
|
||||
| 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 | The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes | ||||
| Official Title | The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes | ||||
| 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 common method to inflate the endotracheal tube cuff is palpation method. However, the palpation of the cuff is not accurate because of the different size between the pilot balloon and the cuff. Thus, the investigators hypothesized that the different size of the tube will affect the accuracy of the palpation method. | ||||
| 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 | Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0 | ||||
| Condition | Intubation, Intratracheal | ||||
| Intervention | Other: cuff pressure of the endotracheal tube
The endotracheal intubation will be performed after the anesthetic induction. The cuff will be inflated using the air by the palpation method. The cuff pressure of the endotracheal tube will be measured using the manometer.
|
||||
| Study Groups/Cohorts | intubation using the endotracheal tube size of 6.0 or 8.0
Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
Intervention: Other: cuff pressure of the endotracheal tube
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
208 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 2020 | ||||
| Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| 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 | NCT03938506 | ||||
| Other Study ID Numbers | 4-2019-0104 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| 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 2019 | ||||
