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Clinical Trials/NCT03902756
NCT03902756CompletedNot Applicable

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

Ramathibodi Hospital1 site in 1 country80 target enrollmentStarted: June 5, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Intra-cuff pressure

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
4 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Flow-Volume loop guided endotracheal cuff inflation

Experimental

Endotracheal cuff will be inflated by Flow-Volume loop guided until getting proper sealing.

Intervention: Endotracheal cuff inflation (Other)

Stethoscope-guided endotracheal cuff infration

Active Comparator

Endotracheal cuff will be inflated by Stethoscope-guided until getting proper sealing.

Intervention: Endotracheal cuff inflation (Other)

Outcomes

Primary Outcomes

Intra-cuff pressure

Time Frame: Immediately after cuff inflation

measuring intra-cuff pressure of endotracheal tube by manometer (cm H2O)

Secondary Outcomes

  • Coughing(24 hours after extubation)
  • Hoarseness(24 hours after extubation)
  • Stridor(24 hours after extubation)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Witchaya Supaopaspan

Principal investigator

Ramathibodi Hospital

Study Sites (1)

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