Verification of Appropriate Insertion Depth of Endotracheal Tube Placement

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

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.

Study Overview

• Status: Unknown
• Conditions: Endotracheal Intubation; Infants or Young Children
• Intervention / Treatment: Other: determination by auscultation; Other: determination by ultrasound

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: 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 Names: H-Universal Stand (sonosite, Bothell, WA, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of inadequate depth of endotracheal tube placement by flexible brochoscopy after intubation	the incidence of inadequate depth of endotracheal tube placement by flexible bronchoscopy 3 minute after intubation	3 minutes after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of repositioning of endotracheal tube placement	incidence of repositioning of endotracheal tube placement (when it is found that the depth of endotracheal tube placement was inadequate determined by saturation fall or airway pressure monitoring)	10 min after anesthetic induction
time to verification of appropriate insertion depth of endotracheal tube placement	time to verification of appropriate insertion depth of endotracheal tube placement by a independent observer	30 minutes after the end of surgery
blood pressure	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)	5, 10, 20 min after anesthetic induction
heart rate	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)	5, 10, 20 min after anesthetic induction
pulse oximetry	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)	5, 10, 20 min after anesthetic induction

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2015
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: June 24, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (ESTIMATE): June 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 11, 2014
• Last Update Submitted That Met QC Criteria: November 10, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: endotracheal intubation; depth of endotracheal tube placement; endobronchial intubation
• Other Study ID Numbers: 2012-05-028-001