Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-03 @ 11:11 PM
Study NCT ID:
NCT04466995
Status:
COMPLETED
Last Update Posted:
2022-02-01
First Post:
2020-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Affecting Endotracheal Cuff Pressure in Gynecological Cases
Sponsor:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Organization:
Study Overview
Official Title:
Factors Affecting Endotracheal Cuff Pressure in Laparoscopic and Laparotomic Gynecological Cases and Its Effect on Postoperative Respiratory Complications
Status:
COMPLETED
Status Verified Date:
2022-01
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:
Postoperative airway complications associated with endotracheal intubation can be seen.
While some of these complications are predictable, some may occur urgently. If the endotracheal cuff is over-inflated and its pressure is high, mucosal damage resulting from mucosal pressure is one of the main factors for tracheal morbidity. Endotracheal tube cuff pressure is not routinely measured. It was confirmed that the palpation of the pilot balloon was insufficient to detect high cuff pressures. In laparoscopic cases, the investigators aimed to investigate whether the increase in intra-abdominal pressure as a result of carbon dioxide insufflation, and the change of respiratory functions after trendelenburg position are effective on cuff pressure and whether there is a difference compared to laparotomic cases.
While some of these complications are predictable, some may occur urgently. If the endotracheal cuff is over-inflated and its pressure is high, mucosal damage resulting from mucosal pressure is one of the main factors for tracheal morbidity. Endotracheal tube cuff pressure is not routinely measured. It was confirmed that the palpation of the pilot balloon was insufficient to detect high cuff pressures. In laparoscopic cases, the investigators aimed to investigate whether the increase in intra-abdominal pressure as a result of carbon dioxide insufflation, and the change of respiratory functions after trendelenburg position are effective on cuff pressure and whether there is a difference compared to laparotomic cases.
Detailed Description:
It was planned to include 50 patients in the American Anesthesiologists Association (ASA) 1-3 risk score group, which will be an elective gynecological operation between the ages of 18-70. When patients arrive in the operating room, after the ECG, pulse oximeter, non-invasive pressure monitoring is provided in the supine position, 18 gauge intravenous(iv) vascular access will be opened and balanced fluid 4-6 ml / kg / h will be inserted. Anesthesia induction with midazolam 0.05 mg / kg, propofol 2-3 mg / kg, Fentanyl 1-2 µg / kg and rocuronium 0.6 mg / kg will be achieved after 3 minutes of preoxygenation. he muscle relaxant effect will be monitored by monitoring TOF (train of four), and after sufficient relaxation (TOF 95%), the anesthetist will be intubated with the 7-7.5 number endotracheal tube suitable for the high-volume low-pressure patient. The cuff of the endotracheal tube will be inflated with the help of an injector and the cuff will be attached to the manometer. Cuff pressures will be inflated to 25 mmHg. The patients will be given oxygen at 40% and air at 3lt / min. The maintenance of anesthesia will be achieved with sevoflurane and 0.05-0.1mcg / kg / min remifentanil infusion.
If the patient feels pain in the perioperative period, 50 mcg fentanyl iv will be used as rescue analgesia. During the operation, rokurunium (0.2mg / kg) boluses will be delivered according to the patient's clinic and the TOF value between 0-2 (depending on the type of surgery). Mechanical ventilation will be started in volume controlled mode with 6-8 ml / kg tidal volume, and 12 frequencies. Respiratory frequencies,tidal volume and positive end expiratory pressure (PEEP) values of patients will be optimized so that end tidal CO2 is 35-45 mmHg throughout the case. At the end of surgery, 100 mg tramadol and 1 g paracetamol will be administered to patients for the purpose of postoperative analgesia. Patients will be extubated after the muscle relaxant is recurrentized with 0.03mg / kg neostigmine and 0.01mg / kg atropine.
If the patient's numeric rating scale (NRS) score is 3 or more during recovery, 0.3 mg / kg Petidine hydrochloride will be applied as rescue analgesia. The 'Case Tracking Form' prepared for the follow-up of the research will be recorded demographically, age, height, weight and BMI information of the patients in the preoperative period.
In the perioperative period, cuff pressures in the supine position after intubation, at the 5th, 15th, 30th, 45th minutes and before extubation will be measured and recorded with the cuff manometer. In addition to the follow-up form, intra-abdominal pressure, PEEP, P peak and P plateau values, anesthesia time, operation time during each measurement will be recorded. Patients who were followed-up in the recovery were evaluated by the service nurse who did not know how to work in the service at the postoperative 1st, 12th, 24th hours, and the NRS (numeric rating scale) (0 is painless, 10 is the most painful and will be asked to describe the pain from 1 to 10); It will be evaluated in terms of dysphagia, cough, sore throat, hoarseness.
If the patient feels pain in the perioperative period, 50 mcg fentanyl iv will be used as rescue analgesia. During the operation, rokurunium (0.2mg / kg) boluses will be delivered according to the patient's clinic and the TOF value between 0-2 (depending on the type of surgery). Mechanical ventilation will be started in volume controlled mode with 6-8 ml / kg tidal volume, and 12 frequencies. Respiratory frequencies,tidal volume and positive end expiratory pressure (PEEP) values of patients will be optimized so that end tidal CO2 is 35-45 mmHg throughout the case. At the end of surgery, 100 mg tramadol and 1 g paracetamol will be administered to patients for the purpose of postoperative analgesia. Patients will be extubated after the muscle relaxant is recurrentized with 0.03mg / kg neostigmine and 0.01mg / kg atropine.
If the patient's numeric rating scale (NRS) score is 3 or more during recovery, 0.3 mg / kg Petidine hydrochloride will be applied as rescue analgesia. The 'Case Tracking Form' prepared for the follow-up of the research will be recorded demographically, age, height, weight and BMI information of the patients in the preoperative period.
In the perioperative period, cuff pressures in the supine position after intubation, at the 5th, 15th, 30th, 45th minutes and before extubation will be measured and recorded with the cuff manometer. In addition to the follow-up form, intra-abdominal pressure, PEEP, P peak and P plateau values, anesthesia time, operation time during each measurement will be recorded. Patients who were followed-up in the recovery were evaluated by the service nurse who did not know how to work in the service at the postoperative 1st, 12th, 24th hours, and the NRS (numeric rating scale) (0 is painless, 10 is the most painful and will be asked to describe the pain from 1 to 10); It will be evaluated in terms of dysphagia, cough, sore throat, hoarseness.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: