NCT04948359

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

July 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

June 28, 2021

Last Update Submit

February 15, 2022

Conditions

CuffAirway EdemaChildren, OnlyTracheal Intubation Morbidity

Keywords

Airway ultrasoundCuffed endotracheal tubeCuff volumeCuff pressureChildren

Outcome Measures

Primary Outcomes (2)

  • Optimal intracuff volume

    To obtain the minimum and optimal cuff volume that will provide adequate ventilation and protect from pulmonary aspiration in pediatric patients who is intubated with cuffed endotracheal tubes inner diameter of 4.5, 5.0, 5.5 mm.

    during surgery

  • Formula for optimal cuff volume.

    We would like to create a formula to calculate the estimated cuff volume that should be inflated within the safe cuff pressure range for each patient intubated with an ETT ID number 4.5, 5.0, and 5.5.

    15 minute

Secondary Outcomes (2)

  • Formula for subglottic transverse tracheal diameter

    15 minute

  • Postoperative complications

    1 hour

Study Arms (3)

Group I (The patients intubated with cuffed ETT of ID number 4.5)

Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 4.5 size internal diameter (ID) endotracheal cuff tube.

Other: Group I (The patients intubated with cuffed ETT of ID number 4.5)

Group II (The patients intubated with cuffed ETT of ID number 5.0)

Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.0 size internal diameter (ID) endotracheal cuff tube.

Other: Group II (The patients intubated with cuffed ETT of ID number 5.0)

Group III (The patients intubated with cuffed ETT of ID number 5.5)

Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.5 size internal diameter (ID) endotracheal cuff tube.

Other: Group III ( The patients intubated with cuffed ETT of ID number 5.5)

Interventions

Group I (The patients intubated with cuffed ETT of ID number 4.5)OTHER

Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 4.5 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)

Group I (The patients intubated with cuffed ETT of ID number 4.5)
Group II (The patients intubated with cuffed ETT of ID number 5.0)OTHER

Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.0 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)

Group II (The patients intubated with cuffed ETT of ID number 5.0)
Group III ( The patients intubated with cuffed ETT of ID number 5.5)OTHER

Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.5 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)

Group III (The patients intubated with cuffed ETT of ID number 5.5)

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric patients younger than 18 yr old who will be operated in our hospital and intubated with cuffed tubes numbered 4.5, 5.0, and 5.5 under general anesthesia

You may qualify if:

  • Pediatric patients younger than 18 yr old who will be operated in our hospital and intubated with cuffed tubes numbered 4.5, 5.0, and 5.5 under general anesthesia are included in this study.

You may not qualify if:

  • ASA physical status score of III and IV,
  • Tracheostomy, airway obstruction or other airway anatomical abnormalities,
  • Difficult intubation prediction,
  • History of airway hyperreactivity or bronchial asthma,
  • Body mass index above the 85th percentile and below the 5th percentile,
  • Patients whose parents were unable to read, understand and sign the consent form or whose parents did not want to sign the consent form will not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (1)

  • Gunes K, Sever F, Ozmert S. Determining optimal cuff volume for cuffed endotracheal tubes commonly used in pediatric patients: A prospective observational study. Saudi Med J. 2024 Feb;45(2):147-153. doi: 10.15537/smj.2024.45.2.20230578.

    PMID: 38309733DERIVED

Study Officials

  • Kahir Güneş

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

  • Sengül Özmert

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

  • Feyza Sever

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist physician

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 1, 2021

Study Start

July 10, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

TU(1)