NCT05013658

Brief Summary

In routine practice, pressure is often attempted to be adjusted by palpation of the cuff pilot balloon of the endotracheal tube. The aim of our study is to investigate the variation of the reliability of the palpation method, which is widely used in cuff pressure measurement in the absence of a manometer, with clinical experience. Our recommendation is to use an accessible manometer if available.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 8, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

August 13, 2021

Last Update Submit

March 4, 2025

Conditions

Endotracheal Tube Cuff Pressure

Outcome Measures

Primary Outcomes (1)

  • experience difference

    After intubation, first the assistant doctor with 0-1 year training period and then the assistant doctor with 4-5 years training period will be asked to inflate the cuff to approximately 25 cm H2O cuff pressure by palpation, and the pressure will be measured with a manometer and recorded.

    four months

Study Arms (2)

junior

ACTIVE COMPARATOR

their anesthesia experiences are between 1 months and 1 year,

Behavioral: pressure measurement

senior

ACTIVE COMPARATOR

Their anesthesia experiences are more than 4 years

Behavioral: pressure measurement

Interventions

pressure measurementBEHAVIORAL

pressure measurement with pilot balloon palpation

juniorsenior

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergo elective operations with general anesthesia.
  • Ages between 18-75
  • ASA I-II-III patients

You may not qualify if:

  • Patient refusal
  • Patients with anticipated difficult airway
  • \- Tempero-mandibular and atlanto-occipitac joint limitation
  • Having ejection fraction less than 35%
  • Peroperative nasogastric tube inserted patients
  • Patients with a history of sore throat, hoarseness, difficulty swallowing before the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Üniversitesi

Kocaeli, Kocaeli̇, 41000, Turkey (Türkiye)

Location

Study Officials

  • TÜLAY ÇARDAKÖZÜ

    KOCAELİ ÜNİVERSİTESİ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor Doctor

Study Record Dates

First Submitted

August 13, 2021

First Posted

August 19, 2021

Study Start

January 8, 2021

Primary Completion

August 25, 2021

Study Completion

September 1, 2021

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)