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| Name | Class |
|---|---|
| Central South University | OTHER |
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In this study, the investigators adopt the special endotracheal tube to those patients at prone posture during the operation,or those with acute respiratory distress syndrome in the intensive care unit(ICU), so that the investigators can reduce, or even avoid some severe complications during perianesthesia, and that the investigators can provide strong safeguard measures for the respiratory therapy of critical patients in ICU.
The investigators apply some technical proposals to make it come true:one kind of special endotracheal tube, including traditional endotracheal tube,fixed device,fixed rope,two through holes.With this tube ,the investigators can keep away shifting and falling off of traditional air tube,so that the investigators can try to avoid disaster events.And for the patients with acute respiratory disease syndrome(ARDS),they are always given ventilation in prone position,so it may be beneficial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prone position endotracheal tube(PPT) | Experimental | the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. |
|
| traditional endotracheal tube(TT) | No Intervention | the subjects of this arm are given the routine endotracheal tube. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prone position endotracheal tube(PPT) | Device | some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Displacement of the Endotracheal Tube | We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance<0.5cm),moderate(0.5cm≤displacement distance<1.5cm),severe (1.5cm≤displacement distance). | Participants were followed for the duration of surgery, an average of 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of the Prolapse of Endotracheal Tube | Counting the number who occured the prolapse of endotracheal tube in both groups | At any time within the procedure of the whole surgery |
| the Degree of Loose or Dampness of the Tape |
| Measure | Description | Time Frame |
|---|---|---|
| the Incidence of Dysphagia | count the number who suffered the dysphagia within the first 24 hours after extubation | within the first 24 hours after extubation |
| the Incidence of Sore Throat | count the number who suffer sore throat within the first 24 hour after extubation |
Inclusion Criteria:
- those who are about to undergo the surgery at prone posture,especially in neurosurgery and spine surgery，American society of anesthesia(ASA) grade I-II，aged from 18 to 65 years old,weight ranged from 50 to 75 kilograms.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wangyuan Zou, MD,phD | Xiangya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wangyuan Zou | Changsha | Hunan | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18211991 | Background | Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380. | |
| 8251716 | Background | Korn S, Schubert A, Barnett G. Endotracheal tube obstruction during stereotactic craniotomy. J Neurosurg Anesthesiol. 1993 Oct;5(4):272-5. doi: 10.1097/00008506-199310000-00008. |
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We finally enrolled 60 patients for our trail. Among the 80 candidates, 7 patients couldn't meet our inclusion criteria; the other 13 patients refused to participate in this trail at last.
We have 80 adult patients as candidates who were undergoing the neurosurgery or spinal surgery in Xiangya Hospital affiliated to Central South University between Mar 11, 2014 and Mar 16, 2016. These participants were graded American society of anesthesia(ASA)I-II,and aged 30-70 years old,weighted ranging from 50 to 75 kilograms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Endotracheal Tube(TT) | the subjects of this arm are given the routine endotracheal tube. |
| FG001 | Prone Position Endotracheal Tube(PPT) | the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all participants in both groups were analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Prone Position Endotracheal Tube(PPT) | We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the prone position endotracheal tube group(PPT), in which group the patients were intubated with the custom-designed endotracheal tube. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Displacement of the Endotracheal Tube | We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance<0.5cm),moderate(0.5cm≤displacement distance<1.5cm),severe (1.5cm≤displacement distance). | All patients in each group were analyzed | Posted | Count of Participants | Participants | Participants were followed for the duration of surgery, an average of 2 hours. |
|
within the postoperative 24 hours
the incidence rate of sore throat, hoarseness, dysphagia in both groups at 24-hour follow-up has been collected and calculated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prone Position Endotracheal Tube | there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat | Skin and subcutaneous tissue disorders | Non-systematic Assessment | after the extubation of endotracheal tube, we investigated the participates whether they occured the sore throat, and the severity. |
No limitations and caveats.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiali Shao | Xiangya Hospital | +8684327413 | zwyfeng@163.com |
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counting and quantifying the number who occured the dampness or loose of the tape in both groups
| at the time when patients were turning to supine position |
| within the first 24 hour after extubation |
| the Incidence of Dysphonia | count the number who suffered dysphonia within the first 24 hour after extubation | within the first 24 hour after extubation |
| 21286458 | Background | Choi RM, Yoon JS, Noh JH, Kang KO, Ryu SW, Jun HJ, Cho SS. Airway obstruction by extrinsic tracheal compression during spinal surgery under prone position -A case report-. Korean J Anesthesiol. 2010 Dec;59 Suppl(Suppl):S45-8. doi: 10.4097/kjae.2010.59.S.S45. Epub 2010 Dec 31. |
| 17510044 | Background | Soundararajan N, Cunliffe M. Anaesthesia for spinal surgery in children. Br J Anaesth. 2007 Jul;99(1):86-94. doi: 10.1093/bja/aem120. Epub 2007 May 17. |
| 18359427 | Background | Tiruvoipati R, Bangash M, Manktelow B, Peek GJ. Efficacy of prone ventilation in adult patients with acute respiratory failure: a meta-analysis. J Crit Care. 2008 Mar;23(1):101-10. doi: 10.1016/j.jcrc.2007.09.003. |
| 20473258 | Background | Gattinoni L, Carlesso E, Taccone P, Polli F, Guerin C, Mancebo J. Prone positioning improves survival in severe ARDS: a pathophysiologic review and individual patient meta-analysis. Minerva Anestesiol. 2010 Jun;76(6):448-54. |
| 20130832 | Background | Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4. |
| 23216936 | Background | Zou W, Zhang W, Li X, Guo Q. A randomized crossover comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in pediatric patients undergoing prone position surgery. Paediatr Anaesth. 2013 Jan;23(1):98-100. doi: 10.1111/pan.12068. No abstract available. |
| 28496141 | Derived | Zou W, Shao J, Liang X, Li L, He Z, Guo Q. A randomized comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in adult patients undergoing prone position surgery. Sci Rep. 2017 May 11;7(1):1769. doi: 10.1038/s41598-017-02006-6. |
| Traditional Endotracheal Tube(TT) |
We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the traditional endotracheal tube group(TT), in which group the patients were intubated with the routine endotracheal tube. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | yr |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| the Traditional Endotracheal Tube |
the subjects of this arm are given the routine endotracheal tube. |
|
|
|
| Secondary | The Number of the Prolapse of Endotracheal Tube | Counting the number who occured the prolapse of endotracheal tube in both groups | All participants in both groups were analyzed | Posted | Count of Participants | Participants | At any time within the procedure of the whole surgery |
|
|
|
|
| Secondary | the Degree of Loose or Dampness of the Tape | counting and quantifying the number who occured the dampness or loose of the tape in both groups | all participants in both groups were analyzed | Posted | Count of Participants | Participants | at the time when patients were turning to supine position |
|
|
|
| Other Pre-specified | the Incidence of Dysphagia | count the number who suffered the dysphagia within the first 24 hours after extubation | all patients were analyzed | Posted | Count of Participants | Participants | within the first 24 hours after extubation |
|
|
|
| Other Pre-specified | the Incidence of Sore Throat | count the number who suffer sore throat within the first 24 hour after extubation | all patients in both groups were analyzed | Posted | Count of Participants | Participants | within the first 24 hour after extubation |
|
|
|
| Other Pre-specified | the Incidence of Dysphonia | count the number who suffered dysphonia within the first 24 hour after extubation | all patients in both groups were analyzed | Posted | Count of Participants | Participants | within the first 24 hour after extubation |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Traditional Endotracheal Tube | there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia. | 0 | 30 | 1 | 30 |
|
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