Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children

• Sponsor: Nationwide Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04061629
• Collaborator: (none)
• Enrollment: 147
• Location: 1
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

Based on standard and historical practice, the predictive size of the endotracheal tube (ETT) to be used in children has been based on various formulas. However, no study has clearly compared these formulas to determine the optimal size of cuffed ETTs. Furthermore, they were developed when using a polyvinylchloride cuff and not the thinner polyurethane cuff which is in common clinical use today. Hence, the purpose of this current study is to evaluate which of the currently available formulas most closely predicts the appropriate size of cuffed ETT to be used based not only on the fit within the trachea, but more importantly the intracuff pressure after the cuff is inflated to seal the airway.

Condition or Disease	Intervention/Treatment	Phase
Surgical Procedure, Unspecified	Device: Cuffed ETT

Study Design

• Study Type: Observational
• Actual Enrollment: 147 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
• Actual Study Start Date: Sep 18, 2017
• Actual Primary Completion Date: Jul 18, 2019
• Actual Study Completion Date: Jul 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group C Size of the cuffed ETT based on the Cole formula = (Age/4) + 4.	Device: Cuffed ETT; Cuffed endotracheal tube.
Group D size of the cuffed ETT based on the Duracher formula = (Age/4) + 3 + 0.5 mm.	Device: Cuffed ETT; Cuffed endotracheal tube.
Group K size of the cuffed ETT based on the Khine formula = (Age/4) + 3.	Device: Cuffed ETT; Cuffed endotracheal tube.

Outcome Measures

Primary Outcome Measures

1. Number of participants that needed their ETT exchanged [Immediately following intubation]

   Having to remove the original ETT and replacing it with a smaller or larger size due to excessive air leak or excessive pressure in the cuff.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children who are less than 8 years of age and are scheduled for surgical procedures requiring endotracheal intubation with a cuffed ETT.

Exclusion Criteria:

• Children with airway anomalies or other factors that may impact tracheal size will be excluded from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Nationwide Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Senthil G. Krishna, Clinical Associate Professor of Anesthesiology, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT04061629
• Other Study ID Numbers: IRB17-00700
• First Posted: Aug 20, 2019
• Last Update Posted: Feb 11, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 11, 2020