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NCT04948359

Determining Optimal Cuff Volume in Pediatric Patients

Completed Last updated 16 February 2022
What this trial tests

trial testing Group I (The patients intubated with cuffed ETT of ID number 4.5) in Cuff in 120 participants. Completed in 1 October 2021.

Timeline
10 July 2021
Primary endpoint
1 October 2021
1 October 2021

Quick facts

Lead sponsorAnkara City Hospital Bilkent
StatusCompleted
Study typeOBSERVATIONAL
Enrollment120
Start date10 July 2021
Primary completion1 October 2021
Estimated completion1 October 2021
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Ankara City Hospital Bilkent

Who can join

Adults 2 to 12, any sex, with Cuff or Airway Edema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background and Aim: Cuffed endotracheal tubes with appropriate size, good cuff design and cuff pressure monitoring in pediatric patients can be used safely without increasing airway morbidity. Inflating the endotracheal tube cuff with more than normal volume may lead to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume may lead to an increase in the risk of inadequate ventilation and pulmonary aspiration. In this study, we aimed to determine an optimal cuff inflation volume to achieve safe cuff pressure (20-25 cm H2O) in cuffed endotracheal tubes with an inner diameter of 4.5, 5.0, 5.5 mm, which are commonly used in pediatric anesthesia clinical practice.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Determining optimal cuff volume for cuffed endotracheal tubes commonly used in pediatric patients: A prospective observational study.
    Güneş K, Sever F, Özmert S. · · 2024 · cited 1× · PMID 38309733 · DOI 10.15537/smj.2024.45.2.20230578

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Other recruiting trials for Cuff

Currently open trials in the same condition.

Other Ankara City Hospital Bilkent trials

Trials by the same sponsor.

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