Investigating the effect of echocardiography probe placement through the esophagus (esophageal echo) on tracheal tube cuff pressure in patients undergoing cardiac surgery.
Determining the effect of placing the endocardiographic probe through the esophagus (esophageal echo) on tracheal tube cuff pressure in patients undergoing cardiac surgery.
Design
A Mallinckrodt tube (Hi-Lo; Mallinckrodt Medical, Athlone, Ireland) with a low-pressure, high-volume cuff will be used in this study. The tracheal tube size will be 7.5 mm for men and 7 mm for women.
Settings and conduct
After successful intubation, the tracheal cuff was manually inflated in heart surgery patients referred to Seyed al-Shohad Hospital until no leakage was heard during lung ventilation. Anesthesia will be maintained with 2-1.5% isoflurane in oxygen, with positive pressure ventilation of the lungs through a circular system. Additional fentanyl and cisatacurium will be prescribed based on the clinical needs of the patients. The thermistor-tipped pulmonary artery and radial artery flotation catheters will then be placed under standard aseptic precautions. Before inserting a fully lubricated TEE probe, a dental guard was placed and gastric contents were drained with an oral tube and then removed. A manometer (Mallinckrodt) will be attached to the endotracheal balloon pilot and adjust the endotracheal cuff pressure to 25-30 cmH2O.
Participants/Inclusion and exclusion criteria
Inclusion criteria for patients undergoing heart valve or coronary artery surgery
Exclusion criteria Patients with tracheal or esophageal stenosis, tracheoesophageal fistula, history of esophageal surgery, esophageal trauma, esophageal varices, esophageal diverticulum, Barrett's esophagus, hiatus hernia, and large bone tears
Intervention groups
Patients undergoing coronary artery or valve transplant surgery will be included in the study
Main outcome variables
Prevention of aspiration of pharyngeal contents; Prevent ischemic changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240721062496N1
Registration date:2024-07-26, 1403/05/05
Registration timing:prospective
Last update:2024-07-26, 1403/05/05
Update count:0
Registration date
2024-07-26, 1403/05/05
Registrant information
Name
sepideh rezazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
sepidehrezazadeh09@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of echocardiography probe placement through the esophagus (esophageal echo) on tracheal tube cuff pressure in patients undergoing cardiac surgery.
Public title
Investigating the effect of echocardiography probe placement through the esophagus (esophageal echo) on tracheal tube cuff pressure in patients undergoing cardiac surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing heart surgery
Coronary artery or valve transplant surgery
Exclusion criteria:
tracheal or oesophageal stricture
tracheo-oesophageal fistula
history of oesophageal surgery
oesophageal varix
oesophageal trauma
oesophageal diverticulum
Barrett’s oesophagus
hiatus hernia
large descending aortic aneurysm or vocal cord paralysis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The effect of intraoperative esophageal device placement (EDI) on endotracheal tube (ET) cuff inflation is unclear. Continued investigation of contributing factors is necessary to continue to improve outcomes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital in Urmia
Street address
Emam khomini university hospital-Eeshad AVE-Modarres Blvd-urmia-iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.UMSU.HIMAM.REC.1403.030
Health conditions studied
1
Description of health condition studied
Echo esophagus probe
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tracheal tube cuff pressure Measurements
Timepoint
Based on different time intervals (T1 at the beginning before inserting the probe, T2. TEE, the maximum pressure during the insertion of the TEE probe. T3, 5 minutes after inserting the TEE probe, and T4, the maximum pressure during the TEE. T5, 5 minutes after the completion of the TEE) .
Method of measurement
Manometer (Mallinckrodt)
2
Description
Airway Pressure Measurements
Timepoint
Peak and mean airway pressures were continuously monitored, intraoperatively,fashion using a pressure transducer connected to the “Y” piece of the anesthesia circuit.
Adjusting the cuff pressure to prevent complications such as sore throat and hoarseness after surgery
Timepoint
immediately at the beginning and every minute after the surgery
Method of measurement
It will be done by an anesthesiologist using a standard manometer
Intervention groups
1
Description
Intervention group:Esophageal echo probe group: Intraesophageal echo is routinely performed by Seris Heart for all patients and no additional intervention is performed by the anesthesia service. In all patients, upon entering the anesthesia induction room, the head and neck are placed in a neutral position and the back of the head is placed on a firm pillow at a height of 5 cm, and standard monitoring will be applied. Anesthesia will be induced with anesthetic drugs. After loss of consciousness, intubation will be performed. In this study, a Mallinckrodt tube (Hi-Lo; Mallinckrodt Medical, Athlone, Ireland) with a low-pressure, high-volume cuff will be used. The tracheal tube size will be 7.5 mm for men and 7 mm for women. The tracheal tube cuff and balloon will be tested for leaks, and then the tracheal cuff will be completely deflated and lubricated with a water-soluble gel before tracheal intubation. After successful intubation, the tracheal cuff was manually inflated until no leaks were heard during ventilation of the lungs. Anesthesia will be maintained with 2-1.5% isoflurane in oxygen, with positive pressure ventilation of the lungs through a circular system. Additional fentanyl and cisatacurium will be prescribed based on the clinical needs of the patients. The thermistor-tipped pulmonary artery and radial artery flotation catheters will then be placed under standard aseptic precautions. Before inserting a fully lubricated TEE probe, a dental guard was placed and gastric contents were drained with an oral tube and then removed. A manometer (Mallinckrodt) will be attached to the endotracheal balloon pilot and adjust the endotracheal cuff pressure to 25-30 cmH2O. After the mandible is elevated and slightly flexed, the TEE probe will be inserted by an anesthetist, who is qualified and experienced in intraoperative TEE. After successful insertion of the probe, the head and neck will be in a neutral position and the tip of the TEE probe will be released in the neutral locked position. The insertion depth for all patients was between 35 and 40 cm.The cuff pressure will be measured immediately at the beginning and every minute until the end of the surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyyed al-Shohada Hospital
Full name of responsible person
Dr. Mitra Golmohammadi
Street address
West Azarbaijan, Urmia, 17th Shahrivar Boulevard, in front of Shahid Samadzadeh Street
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Fax
+98 44 3237 7892
Email
mitragolmohammadi@yahoo.com
Web page address
https://Umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Urmia - Resalat Boulevard - Urmia University of Medical Sciences - Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
saber@umsu.ac.ir
Web page address
https://umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mitra Golmohammadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
West Azarbaijan, Urmia, 17th Shahrivar Boulevard, in front of Shahid Samadzadeh Street
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
mitragolmohammadi@yahoo.com
Web page address
https://umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mitra Golmohammadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
West Azarbaijan, Urmia, 17th Shahrivar Boulevard, in front of Shahid Samadzadeh Street
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
mitragolmohammadi@yahoo.com
Web page address
https://umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mitra Golmohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
West Azarbaijan, Urmia, 17th Shahrivar Boulevard, in front of Shahid Samadzadeh Street
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
mitragolmohammadi@yahoo.com
Web page address
https://umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available