NCT06321835

Brief Summary

Background: The placement of a cuffed endotracheal tube for the administration of general anesthesia is a routine procedure. In the part of the intubation tube located in the trachea, there is a balloon (cuff) to prevent gase leakage, aspiration of secretions and gastric contents into the lungs. Inadequate inflation of cuff may lead to inadequate ventilation, aspiration and associated complications, while excessive inflation may cause complications in ranging from postoperative pharyngeal complaints to tracheal rupture due to increased cuff pressure. This study aimed to determine the effect of different patient positions on the endotracheal cuff pressure in patients undergoing urological procedures. Methods: This is a prospective study conducted on 200 patients undergoing urological procedures in supine, prone, lateral flank and litotomy positions. After intubation (T0), the cuff pressure was checked with a cuff manometer and adjusted at 25 cmH2O as the baseline and continuously monitored. The cuff pressure was checked again before (T1) and after achieving the final position (T2) and then at 5 (T3), 10 (T4), 15 (T5), 30, 45, 60, 90, 120, 150, 180 minutes after the position, at the end of the procedure (T6) and before extubation (T7). At postoperative 2nd and 12th hours, the patients were interviewed for sore throat, hoarseness and cough.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

March 5, 2024

Last Update Submit

March 18, 2024

Conditions

Keywords

endotracheal tubecuff pressurepatient positionpronelateral flanklitotomysore throat

Outcome Measures

Primary Outcomes (1)

  • The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study

    Primary outcome of this study is endotracheal cuff pressure can be changed in patients undergoing urological procedures in different patient positions.

    1 year

Secondary Outcomes (1)

  • The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients

    1 year

Study Arms (4)

Supine Group

The patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy.

Procedure: Endotracheal tube cuff pressure measurement

Prone Group

The patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy.

Procedure: Endotracheal tube cuff pressure measurement

Lithotomy Group

The patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy.

Procedure: Endotracheal tube cuff pressure measurement

Lateral flank group

The patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy.

Procedure: Endotracheal tube cuff pressure measurement

Interventions

This is a prospective study conducted on 200 patients undergoing urological procedures in supine, prone, lateral flank and litotomy positions. After intubation (T0), the cuff pressure was checked with a cuff manometer and adjusted at 25 cmH2O as the baseline and continuously monitored. The cuff pressure was checked again before (T1) and after achieving the final position (T2) and then at 5 (T3), 10 (T4), 15 (T5), 30, 45, 60, 90, 120, 150, 180 minutes after the position, at the end of the procedure (T6) and before extubation (T7). At postoperative 2nd and 12th hours, the patients were interviewed for sore throat, hoarseness and cough.

Lateral flank groupLithotomy GroupProne GroupSupine Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200 patients aged 18-75 years, ASA physical status I-II, who were planned for elective urological surgery in one of the supine, prone, lateral flank or lithotomy position were studied. The patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy

You may qualify if:

  • patients aged 18-75 years
  • ASA physical status I-II
  • Who were planned for elective urological surgery in one of the supine, prone, lateral flank or lithotomy position were studied

You may not qualify if:

  • emergency operation
  • a history of chronic lung disease
  • upper and/or lower respiratory tract infection within 2 weeks before surgery
  • morbid obesity
  • pregnancy
  • laparoscopic surgery
  • single lung ventilation
  • difficut airway
  • hemodynamic instability and/or respiratory complications in the intraoperative period
  • history of mental illness or communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 20, 2024

Study Start

December 9, 2016

Primary Completion

January 15, 2018

Study Completion

June 15, 2018

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share