Mechanical Ventilation ComplicationNCT02449356
Clinical Study of the Endotracheal Tube Used in Prone Position Ventilation Condition
A study testing prone position endotracheal tube(PPT) in people with Mechanical Ventilation Complication, run by Wangyuan Zou at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- prone position endotracheal tube(PPT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- prone position endotracheal tube(PPT)
- Keywords
- Prone position ventilation, Endotracheal intubation, Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone position endotracheal tube(PPT)Device
some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes
| Study group | Role | What they receive |
|---|---|---|
| prone position endotracheal tube(PPT) | Experimental | the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. Receives: Device: prone position endotracheal tube(PPT) |
| traditional endotracheal tube(TT) | No intervention | the subjects of this arm are given the routine endotracheal tube. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Participants were followed for the duration of surgery, an average of 2 hours.
Secondary outcomes (2)
The Number of the Prolapse of Endotracheal Tube
Counting the number who occured the prolapse of endotracheal tube in both groups
Measured: At any time within the procedure of the whole surgery
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
Measured: at the time when patients were turning to supine position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wangyuan Zou
- Sponsor type
- University, hospital or other
- Collaborators
- Central South University
- Responsible party
- Sponsor-investigator, Wangyuan Zou, Central South University
- Investigators
- Wangyuan Zou, MD,phD, Principal investigator, Xiangya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449356
- Sponsor's protocol ID
- 2013L14
- Status last verified
- Mar 2017
- First submitted
- 26 Apr 2015
- Last updated
- 15 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18211991Korn 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.
PubMed 8251716Choi 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.
PubMed 21286458Soundararajan 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.
PubMed 17510044Tiruvoipati 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.
PubMed 18359427Gattinoni 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.
PubMed 20473258Sud 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.
PubMed 20130832Zou 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.
PubMed 23216936Zou 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.
PubMed 28496141
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Endotracheal Tube Used in Prone Position Ventilation Condition
- ClinicalTrials.gov ID
- NCT02449356
- Acronym / sponsor ID
- 2013L14
- Conditions
- Mechanical Ventilation Complication
- Keywords
- Prone position ventilation, Endotracheal intubation, Displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wangyuan ZouUniversity, hospital or other
- Collaborators
- Central South University
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Posted 15 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prone position endotracheal tube(PPT) | Experimental | Device: prone position endotracheal tube(PPT)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No meeting inclusion criteria
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 |
|---|---|---|
| prone position endotracheal tube(PPT)some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes | Device | prone position endotracheal tube(PPT) |
Primary outcome
Displacement of the Endotracheal Tube
Time frame: Participants were followed for the duration of surgery, an average of 2 hours.
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).
2 secondary outcomes
The Number of the Prolapse of Endotracheal Tube
Time frame: At any time within the procedure of the whole surgery
the Degree of Loose or Dampness of the Tape
Time frame: at the time when patients were turning to supine position
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18211991Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380.
- Background: PubMed 8251716Korn 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.
- Background: PubMed 21286458Choi 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.
- Background: PubMed 17510044Soundararajan 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.
- Background: PubMed 18359427Tiruvoipati 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.
- Background: PubMed 20473258Gattinoni 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.
- Background: PubMed 20130832Sud 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.
- Background: PubMed 23216936Zou 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.
- Derived from this study: PubMed 28496141Zou 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.
- 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.
Wangyuan Zou, MD,phD principal investigator
Xiangya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prone position endotracheal tube(PPT) in people with Mechanical Ventilation Complication, run by Wangyuan Zou 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Displacement of the Endotracheal Tube (time frame: Participants were followed for the duration of surgery, an average of 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02449356, which also lists 9 linked publications.
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 15 Jun 2017.