ETT Cuff Leak: TV Ratios

Surgical Procedures, Operative Clinical Trial

Official title:

Minimal Occlusive Pressure With Cuffed ETTs: A Comparison of Two Different Techniques to Ensure a Tracheal Seal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768831
• Other study ID #: IRB16-00222
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: June 28, 2022

Study information

• Verified date: June 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion while an inadequate seal may impact ventilation and potentially increase the risk of aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible leak and measuring the difference between the inspired and expired tidal volumes (TV). This is a prospective study to compare these two methods used to create a tracheal seal and measure the intracuff pressure after a satisfactory tracheal seal is established.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Children who are scheduled to undergo GA with a cuffed ETT in place.

Exclusion Criteria:

• Any children with pre-existing tracheal/bronchial anomalies, patients with Down syndrome, patients with C-spine issues.

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Intervention

Other:
• CPAP
Sealing the airway by holding CPAP of 20 cmH2O in the anesthesia circuit and slowly inflating the cuff until no air leak is heard with a stethoscope placed in the suprasternal notch.
• Tidal volume
The ratio of the inspired to expired tidal volume will be determined using the following formula: (TVinspired - TV¬expired)/TVinspired. The peak inflating pressure (PIP) required to achieve the set TV will be noted. The air in the cuff will then be increased or decreased as needed to achieve a set delivered ratio of 0.9-1.0.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracuff pressure	Difference in intracuff pressure measured after inflation with CPAP and inflation with TV.	Immediately following intubation