Verification of Appropriate Insertion Depth of Endotracheal Tube Placement in Infants and Young Children by Ultrasonography

This study is currently recruiting participants.
Verified June 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01628978
First received: June 24, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

The investigators are trying to evaluate the efficacy of ultrasonographic determination of depth of endotracheal tube placement in infants and young children by using the pleural sliding sign.


Condition Intervention
Endotracheal Intubation
Infants or Young Children
Other: determination by auscultation
Other: determination by ultrasound

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Verification of Appropriate Insertion Depth of Endotracheal Tube Placement in Infants and Young Children by Ultrasonography

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • time to verification of appropriate insertion depth of endotracheal tube placement [ Time Frame: 10 min after anesthetic induction ] [ Designated as safety issue: Yes ]
    time to verification of appropriate insertion depth of endotracheal tube placement by a independent observer


Secondary Outcome Measures:
  • incidence of repositioning of endotracheal tube placement [ Time Frame: 20 min after anesthetic induction ] [ Designated as safety issue: Yes ]
    incidence of repositioning of endotracheal tube placement (when it is found that the depth of endotracheal tube placement was inadequate by pulse oximetry or airway pressure monitoring)

  • the incidence of inadequate depth of endotracheal tube placement by chest X-ray after surgery [ Time Frame: 30 minutes after the end of surgery ] [ Designated as safety issue: Yes ]
    the incidence of inadequate depth of endotracheal tube placement by chest X-ray after surgery assessed by the radiologist

  • blood pressure [ Time Frame: 5, 10, 20 min after anesthetic induction ] [ Designated as safety issue: Yes ]
    systolic, diastolic, mean blood pressure before attempt of endotracheal intubation (5 min), during determining the depth of endotracheal tube placement (10 min), after determining the depth of endotracheal tube placement (20 min)

  • heart rate [ Time Frame: 5, 10, 20 min after anesthetic induction ] [ Designated as safety issue: Yes ]
    heart rate before attempt of endotracheal intubation (5 min), during determining the depth of endotracheal tube placement (10 min), after determining the depth of endotracheal tube placement (20 min)

  • pulse oximetry [ Time Frame: 5, 10, 20 min after anesthetic induction ] [ Designated as safety issue: Yes ]
    pulse oximetry before attempt of endotracheal intubation (5 min), during determining the depth of endotracheal tube placement (10 min), after determining the depth of endotracheal tube placement (20 min)


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Auscultation group
The depth of endotracheal tube placement is determined by auscultation.
Other: determination by auscultation
determination of depth of endotracheal tube placement by auscultation
Other Name: auscultation
Ultrasonography group
The depth of placement of endotracheal tube placement is determined by ultrasonographic finding of pleural sliding sign.
Other: determination by ultrasound
determination of depth of endotracheal tube placement by ultrasound
Other Name: H-Universal Stand (sonosite, Bothell, WA, USA)

Detailed Description:

It is difficult to determine the adequate depth of endotracheal tube placement in infants and young children. It is usually determined by an equation according to the patient's age (12 + age/2, cm) or auscultation method. The auscultation method is to intentionally place the tip of the endotracheal tube into the right main stem bronchus and then withdraw it until breath sounds are equal. The tube is fixed 1 or 2 cm proximal to the point where breath sounds become equal. However, in small children or infant, as the breadth sound in unilateral lung transmits the contralateral lung field and is often difficult to listen in a noisy operation room, it is often difficult to determine the depth by auscultation method. Pleural sliding sign, or sliding lung sign is a ultrasonographic finding that the visceral pleura moves against the parietal pleura. It is used to identify whether the lung is ventilated by ultrasound. The investigators are trying to use this pleural sliding sign to determine the depth of endotracheal tube, and compare this method with auscultation method.

  Eligibility

Ages Eligible for Study:   1 Month to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants or young children (less than body weight of 20 kg) undergoing elective surgery (general surgery, urology, plastic surgery, otolaryngologic surgery, cardiac surgery) under general anesthesia with endotracheal intubation

Criteria

Inclusion Criteria:

  • Infants or young children (less than body weight of 20 kg) undergoing elective surgery (general surgery, urology, plastic surgery, cardiac surgery) under general anesthesia with endotracheal intubation

Exclusion Criteria:

  • Patients with pneumothorax, pleural effusion, atelectasis, pneumonia
  • hemodynamic unstable patients (inotropics use)
  • History of difficult intubation
  • Combined upper airway anomaly
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628978

Contacts
Contact: Sangmin M. Lee, MD, PhD 82-2-3410-0362 sangminm.lee@samsung.com
Contact: Won Ho Kim, MD 82-2-3410-1994 bullet57@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Sangmin M. Lee, MD, PhD    82-2-3410-0362    sangminm.lee@samsung.com   
Contact: Won Ho Kim, MD    82-2-3410-1994    bullet57@naver.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sangmin M. Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Sangmin M. Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01628978     History of Changes
Other Study ID Numbers: 2012-05-028-001
Study First Received: June 24, 2012
Last Updated: June 26, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
depth of endotracheal tube placement
endotracheal intubation
endobronchial intubation

ClinicalTrials.gov processed this record on April 17, 2014