Pediatric Endotracheal Intubation (no Specific Condition)ET_TubeNCT02131974
Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff
An observational study of Pediatric Endotracheal Intubation (no Specific Condition), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this research study is to help determine if the cuff of an endotracheal tube ( ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if visualization of this tube corresponds with correct tube depth. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pediatric Endotracheal Intubation (no Specific Condition)
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2013to 10 Oct 2014
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients scheduled to undergo elective cardiac catherization procedures will be screened for eligibility.
Who may be able to join
- English and Spanish-speaking patients
- Age 0-21 years
- Elective cardiac catheterization procedure
- Endotracheal intubation with a cuffed ETT
Who cannot join
- Abnormal neck/tracheal anatomy
- Emergent cardiac catherization procedure
- Endotracheal intubation with an uncuffed ETT
- Inability to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hermann Hospital
Houston, Texas, 77030
About this study
The purpose of this research study is to help determine if the cuff of an endotracheal tube ( ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if visualization of this tube corresponds with correct tube depth. You are being asked to participate because you will be undergoing a cardiac catherization procedure which will involve endotracheal intubation.
Ultrasound is a safe technology that your doctor could possibly use to see the breathing tube. Right now, x-rays, which come with their own risks, are being used for this purpose. We are trying to see if we can avoid using x-rays.
This is a local study with 1 location. The study will enroll a total of 71 people. There is no sponsor for this study.
Read the detailed description
If you enter the study, in the cardiac catheterization lab, after the anesthesiologist has done his part (placed the breathing tube while you are asleep and obtained the x-ray), we will use the ultrasound to check the position of the breathing tube. To help us see the breathing tube better, we will put some fluid in the cuff ( the balloon at the tip of the breathing tube). The tube may be repositioned as needed based on the chest x-ray. The entire procedure is estimated to take no more than 10 minutes.
- Keywords
- intubation, pediatric, endotracheal, cuffed ETT
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of Ultrasound
Determine the reliability of ultrasound in visualizing a saline-filled cuff of the ETT in pediatric patients.
Measured: 10 minutes
Secondary outcomes (1)
Reliability of visualizing the cuff in patients without initial visualized cuff
In patients without an initial visualized cuff, determine the reliability of ultrasound in visualizing the cuff after a single retraction of the tube (as deemed permissible by cinefluoroscopy).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study start22 Oct 2013
- Primary completion10 Oct 2014
- Study completion10 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pediatric Endotracheal Intubation (no Specific Condition)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131974
- Sponsor's protocol ID
- HSC-MS-13-0324
- Acronym
- ET_Tube
- Status last verified
- Oct 2018
- First submitted
- 2 May 2014
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sakles JC, Laurin EG, Rantapaa AA, Panacek EA. Airway management in the emergency department: a one-year study of 610 tracheal intubations. Ann Emerg Med. 1998 Mar;31(3):325-32. doi: 10.1016/s0196-0644(98)70342-7.
PubMed 9506489Gausche M, Lewis RJ, Stratton SJ, Haynes BE, Gunter CS, Goodrich SM, Poore PD, McCollough MD, Henderson DP, Pratt FD, Seidel JS. Effect of out-of-hospital pediatric endotracheal intubation on survival and neurological outcome: a controlled clinical trial. JAMA. 2000 Feb 9;283(6):783-90. doi: 10.1001/jama.283.6.783.
PubMed 10683058Vanden Hoek TL, Morrison LJ, Shuster M, Donnino M, Sinz E, Lavonas EJ, Jeejeebhoy FM, Gabrielli A. Part 12: cardiac arrest in special situations: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S829-61. doi: 10.1161/CIRCULATIONAHA.110.971069. No abstract available.
PubMed 20956228Li J. Capnography alone is imperfect for endotracheal tube placement confirmation during emergency intubation. J Emerg Med. 2001 Apr;20(3):223-9. doi: 10.1016/s0736-4679(00)00318-8.
PubMed 11267809Galicinao J, Bush AJ, Godambe SA. Use of bedside ultrasonography for endotracheal tube placement in pediatric patients: a feasibility study. Pediatrics. 2007 Dec;120(6):1297-303. doi: 10.1542/peds.2006-2959.
PubMed 18055679Drescher MJ, Conard FU, Schamban NE. Identification and description of esophageal intubation using ultrasound. Acad Emerg Med. 2000 Jun;7(6):722-5. doi: 10.1111/j.1553-2712.2000.tb02055.x. No abstract available.
PubMed 10905655Werner SL, Smith CE, Goldstein JR, Jones RA, Cydulka RK. Pilot study to evaluate the accuracy of ultrasonography in confirming endotracheal tube placement. Ann Emerg Med. 2007 Jan;49(1):75-80. doi: 10.1016/j.annemergmed.2006.07.004. Epub 2006 Oct 2.
PubMed 17014927Weaver B, Lyon M, Blaivas M. Confirmation of endotracheal tube placement after intubation using the ultrasound sliding lung sign. Acad Emerg Med. 2006 Mar;13(3):239-44. doi: 10.1197/j.aem.2005.08.014. Epub 2006 Feb 22.
PubMed 16495415Kerrey BT, Geis GL, Quinn AM, Hornung RW, Ruddy RM. A prospective comparison of diaphragmatic ultrasound and chest radiography to determine endotracheal tube position in a pediatric emergency department. Pediatrics. 2009 Jun;123(6):e1039-44. doi: 10.1542/peds.2008-2828. Epub 2009 May 4.
PubMed 19414520Raphael DT, Conard FU 3rd. Ultrasound confirmation of endotracheal tube placement. J Clin Ultrasound. 1987 Sep;15(7):459-62. doi: 10.1002/jcu.1870150706.
PubMed 3134447Uya A, Spear D, Patel K, Okada P, Sheeran P, McCreight A. Can novice sonographers accurately locate an endotracheal tube with a saline-filled cuff in a cadaver model? A pilot study. Acad Emerg Med. 2012 Mar;19(3):361-4. doi: 10.1111/j.1553-2712.2012.01306.x.
PubMed 22435870Matsuo K, Akata T, Yamaura K, Morikawa K, Kandabashi T, Ueda N, Tohyama K, Takahashi S. [Intraoperative monitoring of pressure within saline-filled, endotracheal tube cuff in adult patients undergoing CO2 laser laryngomicrosurgery]. Masui. 2002 May;51(5):482-8. Japanese.
PubMed 12058429
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff
- ClinicalTrials.gov ID
- NCT02131974
- Acronym / sponsor ID
- ET_Tube / HSC-MS-13-0324
- Keywords
- intubation, pediatric, endotracheal, cuffed ETT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 22 Oct 2013 (actual)
- Primary completion
- 10 Oct 2014 (actual)
- Study completion
- 10 Oct 2014 (actual)
- First posted
- 6 May 2014 (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.
The purpose of this research study is to help determine if the cuff of an endotracheal tube ( ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if visualization of this tube corresponds with correct tube depth. You are being asked to participate because you will be undergoing a cardiac catherization procedure which will involve endotracheal intubation.
Ultrasound is a safe technology that your doctor could possibly use to see the breathing tube. Right now, x-rays, which come with their own risks, are being used for this purpose. We are trying to see if we can avoid using x-rays.
This is a local study with 1 location. The study will enroll a total of 71 people. There is no sponsor for this study.
Detailed description
If you enter the study, in the cardiac catheterization lab, after the anesthesiologist has done his part (placed the breathing tube while you are asleep and obtained the x-ray), we will use the ultrasound to check the position of the breathing tube. To help us see the breathing tube better, we will put some fluid in the cuff ( the balloon at the tip of the breathing tube). The tube may be repositioned as needed based on the chest x-ray. The entire procedure is estimated to take no more than 10 minutes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients scheduled to undergo elective cardiac catherization procedures will be screened for eligibility.
Key inclusion criteria (4 listed)
- English and Spanish-speaking patients
- Age 0-21 years
- Elective cardiac catheterization procedure
- Endotracheal intubation with a cuffed ETT
Key exclusion criteria (4 listed)
- Abnormal neck/tracheal anatomy
- Emergent cardiac catherization procedure
- Endotracheal intubation with an uncuffed ETT
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability of Ultrasound
Time frame: 10 minutes
Determine the reliability of ultrasound in visualizing a saline-filled cuff of the ETT in pediatric patients.
1 secondary outcome
Reliability of visualizing the cuff in patients without initial visualized cuff
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Background: PubMed 9506489Sakles JC, Laurin EG, Rantapaa AA, Panacek EA. Airway management in the emergency department: a one-year study of 610 tracheal intubations. Ann Emerg Med. 1998 Mar;31(3):325-32. doi: 10.1016/s0196-0644(98)70342-7.
- Background: PubMed 10683058Gausche M, Lewis RJ, Stratton SJ, Haynes BE, Gunter CS, Goodrich SM, Poore PD, McCollough MD, Henderson DP, Pratt FD, Seidel JS. Effect of out-of-hospital pediatric endotracheal intubation on survival and neurological outcome: a controlled clinical trial. JAMA. 2000 Feb 9;283(6):783-90. doi: 10.1001/jama.283.6.783.
- Background: PubMed 20956228Vanden Hoek TL, Morrison LJ, Shuster M, Donnino M, Sinz E, Lavonas EJ, Jeejeebhoy FM, Gabrielli A. Part 12: cardiac arrest in special situations: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S829-61. doi: 10.1161/CIRCULATIONAHA.110.971069. No abstract available.
- Background: PubMed 11267809Li J. Capnography alone is imperfect for endotracheal tube placement confirmation during emergency intubation. J Emerg Med. 2001 Apr;20(3):223-9. doi: 10.1016/s0736-4679(00)00318-8.
- Background: PubMed 18055679Galicinao J, Bush AJ, Godambe SA. Use of bedside ultrasonography for endotracheal tube placement in pediatric patients: a feasibility study. Pediatrics. 2007 Dec;120(6):1297-303. doi: 10.1542/peds.2006-2959.
- Background: PubMed 10905655Drescher MJ, Conard FU, Schamban NE. Identification and description of esophageal intubation using ultrasound. Acad Emerg Med. 2000 Jun;7(6):722-5. doi: 10.1111/j.1553-2712.2000.tb02055.x. No abstract available.
- Background: PubMed 17014927Werner SL, Smith CE, Goldstein JR, Jones RA, Cydulka RK. Pilot study to evaluate the accuracy of ultrasonography in confirming endotracheal tube placement. Ann Emerg Med. 2007 Jan;49(1):75-80. doi: 10.1016/j.annemergmed.2006.07.004. Epub 2006 Oct 2.
- Background: PubMed 16495415Weaver B, Lyon M, Blaivas M. Confirmation of endotracheal tube placement after intubation using the ultrasound sliding lung sign. Acad Emerg Med. 2006 Mar;13(3):239-44. doi: 10.1197/j.aem.2005.08.014. Epub 2006 Feb 22.
- Background: PubMed 19414520Kerrey BT, Geis GL, Quinn AM, Hornung RW, Ruddy RM. A prospective comparison of diaphragmatic ultrasound and chest radiography to determine endotracheal tube position in a pediatric emergency department. Pediatrics. 2009 Jun;123(6):e1039-44. doi: 10.1542/peds.2008-2828. Epub 2009 May 4.
- Background: PubMed 3134447Raphael DT, Conard FU 3rd. Ultrasound confirmation of endotracheal tube placement. J Clin Ultrasound. 1987 Sep;15(7):459-62. doi: 10.1002/jcu.1870150706.
- Background: PubMed 22435870Uya A, Spear D, Patel K, Okada P, Sheeran P, McCreight A. Can novice sonographers accurately locate an endotracheal tube with a saline-filled cuff in a cadaver model? A pilot study. Acad Emerg Med. 2012 Mar;19(3):361-4. doi: 10.1111/j.1553-2712.2012.01306.x.
- Background: PubMed 12058429Matsuo K, Akata T, Yamaura K, Morikawa K, Kandabashi T, Ueda N, Tohyama K, Takahashi S. [Intraoperative monitoring of pressure within saline-filled, endotracheal tube cuff in adult patients undergoing CO2 laser laryngomicrosurgery]. Masui. 2002 May;51(5):482-8. Japanese.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Endotracheal Intubation (no Specific Condition), run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 4 inclusion and 4 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 12 Oct 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reliability of Ultrasound (time frame: 10 minutes). 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 NCT02131974, which also lists 12 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 12 Oct 2018.