Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff

NCT ID: NCT02131974

Last Updated: 2018-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-22

Study Completion Date

2014-10-10

Brief Summary

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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

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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.

Conditions

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Pediatric Endotracheal Intubation (no Specific Condition)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* English and Spanish-speaking patients
* Age 0-21 years
* Elective cardiac catheterization procedure
* Endotracheal intubation with a cuffed ETT

Exclusion Criteria

* Abnormal neck/tracheal anatomy
* Emergent cardiac catherization procedure
* Endotracheal intubation with an uncuffed ETT
* Inability to consent
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Memorial Hermann Hospital

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9506489 (View on PubMed)

Gausche 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.

Reference Type BACKGROUND
PMID: 10683058 (View on PubMed)

Vanden 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.

Reference Type BACKGROUND
PMID: 20956228 (View on PubMed)

Li 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.

Reference Type BACKGROUND
PMID: 11267809 (View on PubMed)

Galicinao 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.

Reference Type BACKGROUND
PMID: 18055679 (View on PubMed)

Drescher 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.

Reference Type BACKGROUND
PMID: 10905655 (View on PubMed)

Werner 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.

Reference Type BACKGROUND
PMID: 17014927 (View on PubMed)

Weaver 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.

Reference Type BACKGROUND
PMID: 16495415 (View on PubMed)

Kerrey 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.

Reference Type BACKGROUND
PMID: 19414520 (View on PubMed)

Raphael DT, Conard FU 3rd. Ultrasound confirmation of endotracheal tube placement. J Clin Ultrasound. 1987 Sep;15(7):459-62. doi: 10.1002/jcu.1870150706.

Reference Type BACKGROUND
PMID: 3134447 (View on PubMed)

Uya 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.

Reference Type BACKGROUND
PMID: 22435870 (View on PubMed)

Matsuo 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.

Reference Type BACKGROUND
PMID: 12058429 (View on PubMed)

Other Identifiers

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HSC-MS-13-0324

Identifier Type: -

Identifier Source: org_study_id

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