Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353932
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-03-14
Brief Title:
The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range on the Incidence of Post-surgery Cough Sore Throat Hoarseness
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of our prospective randomized controlled double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat hoarseness and coughThe secondary aims of our study are to evaluate the effect of intubation duration smoking presence of chest disease presence of blood on the intubation tube after extubation presence of NGOG and type of surgery on the incidence of sore throat hoarseness and coughThe patients were randomly divided into two a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoringThe endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation before extubation and in long cases at the 3rd hour after intubationPatients were evaluated for sore throat cough and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups
Detailed Description:
Although the safe cuff pressure range for high volume-low pressure tubes used today is defined as 20-30 cmH2O routine cuff pressure monitoring is not performed in operating rooms The aim of this study is to investigate whether there is a significant pressure difference between blindly inflated cuffs and the cuffs inflated by controlling the cuff pressure aided by monitorization and the effects of any detected pressure difference on the trachea using the clinically detectable parameters of sore throat hoarseness and cough The patients included in this prospective controlled randomized double-blind study were divided into two groups the study group whose cuff pressures were monitored continously n 163 and the control group n 100 The study group was constantly monitored with an invasive pressure monitoring system In addition a researcher who was blind to the groups measured the endotracheal tube cuff pressure with the help of a manometer after intubation in both groups before extubation and in long-term cases at the 3rd hour after intubation Postoperatively patients were evaluated for sore throat cough and hoarseness using VAS scoring at the 2nd and 24th hour by another researcher blinded to the study groups Statistical evaluation was made using the Statistical Package for Social Sciences for Windows 20 SPSS-IBM SPSS Inc Chicago IL program Complaint of sore throat was observed significantly less at 2nd and 24th hours in the group with cuff pressure monitoring p000 for 2nd hour sore throat p002 for 24th hour sore throat No difference was detected between the groups in terms of hoarseness and cough It has been observed that manometer measurements also reduce the pressure due to the use of air in the same closed system The quantity of this reduction which some researchers have previously stated needs to be studied in more detail In conclusion intraoperative ETT cuff pressure monitoring may be effective in preventing sore throat and the mucosal ischemia that causes this pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None