Postoperative ComplicationsNCT02666300
To Compare the Incidence of POST Between a TaperGuard ETT and Cylindrical-shaped ETT Under High Cuff Pressure
A study testing TaperGuard ETT in people with Postoperative Complications, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- TaperGuard ETT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Feb 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General anesthesia surgery
- aged 18 to 75 years
- ASA classⅠ or Ⅱ
- undergoing elective non-throat and non-neck surgery under generalanesthesia
- intubation timemore than two hours
- BMI≤30 kg／m2
Who cannot join
- Patients with ahistory of preoperative sore throat
- known airway disease and difficult intubation
- more than one attempt at intubation
- Mallampati grade 3 to 4
- Cormack-Lehane grade3 to 4
- BMI >35 Kg/m2
- Those have an operation with the lateral flank or prone position
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Xiao Z yang, MD,PhD, 0866-17709873399
About this study
Official title: To Compare the Incidence of Postoperative Sore Throat Between a TaperGuardEndotracheal Tube(ETT)and a Cylindrical-shaped ETT Under Highcuffpressure:A Randomized,Double-blindTrial.
Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.
Read the detailed description
BACKGROUND:Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Endotracheal tube size ,airway manipulation ,patients position et al. have been recognized as the factors affecting Postoperative Sore Throat .Controversy in respect of the relationship between the cuff design and POST is still existed. Whether the new type of ETT (TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.
METHODS:Patients undergoing elective non-throat and non-neck surgery were randomly allocated to receive either a TaperGuard ETT(group T) or Cylindrical-shaped ETT ( Group C).Patients received general anesthesia with different endotracheal tubes .Recoil of inflation syringe plunger was used to inflate the cuff. In the study , the cuff pressures of the endotracheal tube were recorded by a calibrated cuff manometer at two time: when the intubation was complited and before endotracheal tube was removed. The incidence and severity of Postoperative Sore Throat(POST),hoarseness, cough were collected by a single investigator blinded to the experiment at 0, 1,6, 12, and 24 hours post-operation.
- Conditions
- Postoperative Complications
- Being tested
- TaperGuard ETT
- Keywords
- Postoperative sore throat,Anesthesia
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaperGuard ETTOther
tracheal intubation with TaperGuard ETT
| Study group | Role | What they receive |
|---|---|---|
| TaperGuard ETT | Experimental | tracheal intubation with the TaperGuard ETT，the ETT cuff is Taper-shangped. Receives: Other: TaperGuard ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative
Measured: 0,1,,6,12,24 hours post-operative
The incidence and severity of Participants with Cylindrical ETT at 0,1,,6,12,24 hours post-operative
Measured: 0,1,,6,12,24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao Z Yang, MD,PhD, Principal investigator, The Second Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666300
- Sponsor's protocol ID
- post2015taper
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Incidence of Postoperative Sore Throat Between a TaperGuardEndotracheal Tube(ETT)and a Cylindrical-shaped ETT Under Highcuffpressure:A Randomized,Double-blindTrial.
- ClinicalTrials.gov ID
- NCT02666300
- Acronym / sponsor ID
- post2015taper
- Conditions
- Postoperative Complications
- Keywords
- Postoperative sore throat,Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- 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.
Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.
Detailed description
BACKGROUND:Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Endotracheal tube size ,airway manipulation ,patients position et al. have been recognized as the factors affecting Postoperative Sore Throat .Controversy in respect of the relationship between the cuff design and POST is still existed. Whether the new type of ETT (TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.
METHODS:Patients undergoing elective non-throat and non-neck surgery were randomly allocated to receive either a TaperGuard ETT(group T) or Cylindrical-shaped ETT ( Group C).Patients received general anesthesia with different endotracheal tubes .Recoil of inflation syringe plunger was used to inflate the cuff. In the study , the cuff pressures of the endotracheal tube were recorded by a calibrated cuff manometer at two time: when the intubation was complited and before endotracheal tube was removed. The incidence and severity of Postoperative Sore Throat(POST),hoarseness, cough were collected by a single investigator blinded to the experiment at 0, 1,6, 12, and 24 hours post-operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TaperGuard ETT | Experimental | Other: TaperGuard ETTtracheal intubation with the TaperGuard ETT，the ETT cuff is Taper-shangped. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- General anesthesia surgery
- aged 18 to 75 years
- ASA classⅠ or Ⅱ
- undergoing elective non-throat and non-neck surgery under generalanesthesia
- intubation timemore than two hours
Key exclusion criteria (7 listed)
- Patients with ahistory of preoperative sore throat
- known airway disease and difficult intubation
- more than one attempt at intubation
- Mallampati grade 3 to 4
- Cormack-Lehane grade3 to 4
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 |
|---|---|---|
| TaperGuard ETTtracheal intubation with TaperGuard ETT | Other | TaperGuard ETT |
Primary outcome
The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative
Time frame: 0,1,,6,12,24 hours post-operative
The incidence and severity of Participants with Cylindrical ETT at 0,1,,6,12,24 hours post-operative
Time frame: 0,1,,6,12,24 hours post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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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.
Xiao Z Yang, MD,PhD principal investigator
The Second Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaperGuard ETT in people with Postoperative Complications, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 28 Jan 2016. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao zhao Yang, MD,PhD (0866-17709873399 ext. 0866, 524798465@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative (time frame: 0,1,,6,12,24 hours post-operative). The study lists 2 primary outcomes in all. 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 28 Jan 2016.