Comparison Between Two Endotracheal Tube Cuff Inflation Methods

March 9, 2020 updated by: Witchaya Supaopaspan, Ramathibodi Hospital

Comparison Between Two Endotracheal Tube Cuff Inflation Methods; Flow Volume Loop Guided vs. Just Seal by Stethoscope Guided in Pediatric Patients

This study is a prospective randomized controlled trial, the primary aim of this study to compare the intracuff pressure which is performed by 2 inflation methods. ( study in pediatric patients 4-12 year old) Group1 : Flow -Volume Loop-guided cuff inflation Group2 : Stethoscope-guided cuff inflation Our hypothesis is Flow-Volume Loop-guided cuff pressure will be lower than Stethoscope-guided cuff pressure.

This study also collect the incidence of common post-extubation respiratory adverse events coughing, hoarseness, stridor, croup as an secondary outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Historically, pediatric anesthesiologists abstained from using cuff-endotracheal tubes in children younger than 8 year of age because of the anatomical particularises of their airway and thus the increased risk of postintubation tracheal damage especially when Nitrous oxide is used for long procedures. In addition the tube size shoud be half size reduced when cuffed endotracheal tube is used, leading to higher airway resistance and increased risk of tube obstruction.

Recently, the use of Cuffed endotracheal tube has been increasing in children younger than 8 year of age who undergoing general anesthesia. Due to several reasons as follows 1) an increasingly sophisticated understanding of developing laryngeal anatomy 2) vastly improved materials in the manufacture of endotracheal tubes 3) cuffed endotracheal tubes serve several advantages over uncuffed endotracheal tubes including fewer laryngoscopies to replace ill-fitting tubes, less contamination of operating room with anesthetic gases, reliable capnography monitoring, better protection against aspiration, adequate ventilation with a low fresh gas flow which allow using low flow anesthsia, and also they are advantageous for certain operations such as laparoscopic/ airway procedures. 4) data are plentiful supporting the equal safety of using cuffed endotracheal tubes compared with uncuffed tubes in children However, using cuffed endotracheal tubes without being careful of cuff pressure may result in damage to tracheal mucosal wall especially in pediatric patients. The intra-cuff pressure should be monitored and maintained at the level below 25 cm H2O. The intra-cuff pressure more than 30 cmH2O causes obstruction to mucosal blood flow and increasing the risk of airway mucosal injury. Cuff pressure measurement by manometer is a gold standard, nevertheless manometer is not available in every operating room. Almost of anesthetists often use either manual palpation of pilot balloon or stethoscope-guided to inflate endotracheal tube cuff.

In adult studies, they found that endotracheal tube cuff pressure estimated by palpation even with experience personals is often much higher than 25-30 cmH2O. Therefore this inflation technique should be avoided in pediatric patients.

As for, stethoscope-guided endotracheal cuff inflation which pediatric anesthesiologists usually use for children. There were several studies in adult patients, they found the median cuff pressure from this inflation technique was 20 (16-28) cmH2O which is in acceptable tracheal cuff pressure.

In routine practice of general anesthesia rarely have continuous cuff pressure monitoring. When Nitrous Oxide is used for general anesthesia, the intra-cuff pressure can increase with time. Accordingly, it will be better to keep intra-cuff pressure as low as having proper sealing.

A couple studies from adult, compared endotracheal tube cuff inflation techniques between Pressure-Volume(PV) loop guided and stethoscope-guided and the results were intra-cuff pressure from PV loop guided was less than stethoscope guided. Moreover cuff-related complications ( coughing, sorethroat) were less in PV loop group also. It seems PV loop guided can provide least cuff pressure with efficient sealing.

This study would like to compare endotracheal cuff pressure that are performed by 2 techniques between Flow-Volume(FV) loop guided and stethoscope-guided in pediatric patients Intra-cuff pressure will be the primary outcome and we will also collect postoperative respiratory complications such as coughing, stridor, hoarseness as secondary outcomes.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Ratchathewi
      • Bangkok, Ratchathewi, Thailand, 10400
        • Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients are undergoing an operations in Ramathibodi hospital.
  • American Society of Anesthesiologists physical status class 1-2
  • Endotracheal tube intubation is needed for an operation
  • Consent to participate in research project.

Exclusion Criteria:

  • Patient who is a predicted difficult intubation
  • Patient who has lung disease, airwar abnormalities
  • Patient who has pulmonary aspiration risk
  • Patient who has a previous sorethroat, hoarseness, respiratory tract infection in last 2 weeks
  • Refused to participate in research project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flow-Volume loop guided endotracheal cuff inflation
Endotracheal cuff will be inflated by Flow-Volume loop guided until getting proper sealing.
Other: Endotracheal cuff inflation
Endotracheal cuff inflation is putting the air in to the endotracheal tube cuff to make the proper sealing.
Active Comparator: Stethoscope-guided endotracheal cuff infration
Endotracheal cuff will be inflated by Stethoscope-guided until getting proper sealing.
Other: Endotracheal cuff inflation
Endotracheal cuff inflation is putting the air in to the endotracheal tube cuff to make the proper sealing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-cuff pressure
Time Frame: Immediately after cuff inflation
measuring intra-cuff pressure of endotracheal tube by manometer (cm H2O)
Immediately after cuff inflation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coughing
Time Frame: 24 hours after extubation
incidence of coughing
24 hours after extubation
Hoarseness
Time Frame: 24 hours after extubation
incidence of hoarseness
24 hours after extubation
Stridor
Time Frame: 24 hours after extubation
incidence of stridor
24 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Witchaya Supaopaspan, medical, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2018

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 04-61-24ว

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endotracheal Cuff Pressure

Clinical Trials on Endotracheal cuff inflation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe