Clinical Trials Logo
  1. Home
  2. Surgical Procedure, Unspecified
  3. NCT04061629
  4. Details
NCT04061629 Clinical Trial

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

Surgical Procedure, Unspecified Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04061629
Other study ID # IRB17-00700
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2017
Est. completion date July 18, 2019

Study information
Verified date February 2020
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 147
Est. completion date July 18, 2019
Est. primary completion date July 18, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 8 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cuffed ETT
Cuffed endotracheal tube.

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 Number of participants that needed their ETT exchanged 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. Immediately following intubation
See also
  Status Clinical Trial Phase
Completed NCT03299920 - Opioid Consumption After Knee Arthroscopy N/A
Not yet recruiting NCT03213548 - Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty N/A
Completed NCT06164158 - Role of Procedural Videos in Teaching the Surgery Residents N/A
Recruiting NCT03854669 - Experimental Pain Reporting Accuracy and Clinical Post-operative Pain N/A
Active, not recruiting NCT03776591 - Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer N/A
Completed NCT04332679 - Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4
Completed NCT05008107 - Virtual Reality as a Perioperative Teaching Tool for Families N/A
Terminated NCT02399111 - A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients N/A
Terminated NCT00753766 - Multifactorial Pre-operative Intervention in Diabetes Mellitus N/A
Active, not recruiting NCT03684720 - Using 'Guided-Discovery-Learning' to Optimize and Maximize Transfer of Surgical Simulation N/A
Recruiting NCT04134975 - Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study N/A
Completed NCT06148701 - Preoperative Anesthesia Automatic System:a Retrospective Cohort Study
Active, not recruiting NCT04202874 - A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology Phase 3
Completed NCT05428579 - Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma
Completed NCT02626546 - Predictors, Risk Factors and Outcome Following Major Surgery
Recruiting NCT06278610 - Pelvic Exenteration and Laterally Extended Pelvic Resection
Recruiting NCT05044832 - Decreasing Emergence Agitation With Personalized Music N/A
Completed NCT04327895 - Surgery in Context of Terrorist Attack : a Survey of French Surgeons
Completed NCT04900233 - Effect of Covid-19 Pandemic in Non Covid-19 Patients at the Emergency Surgical Department