Verification of Appropriate Insertion Depth of Endotracheal Tube Placement

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01628978
• Other study ID #: 2012-05-028-001
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2012
• Last updated: November 10, 2014
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2014
• Source: Samsung Medical Center
• Contact: Sangmin M. Lee, MD, PhD
• Phone: 82-2-3410-0362
• Email: sangminm.lee[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 10 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Endotracheal Intubation
• Infants or Young Children

Intervention

Other:
• determination by auscultation
determination of depth of endotracheal tube placement by auscultation
• determination by ultrasound
determination of depth of endotracheal tube placement by ultrasound

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes