Factors Affecting Endotracheal Cuff Pressure in Gynecological Cases

Intubation Complication Clinical Trial

Official title:

Factors Affecting Endotracheal Cuff Pressure in Laparoscopic and Laparotomic Gynecological Cases and Its Effect on Postoperative Respiratory Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466995
• Other study ID #: 2020/92
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2022
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female patients between 18-70 years old who will undergo gynecological abdominal surgery

• Patients with American Society of Anesthesiologists physical status 1-3

• Patients who will undergo elective surgery

Exclusion Criteria:

• Patients with tracheotomy

• Patients with detected tracheal stenosis

• Patients with laryngeal disease or laryngeal surgery

• Patients with difficult airway (intubated after 2 or more attempts)

• Patients with BMI> 35

• Patients receiving chronic obstructive pulmonary disease treatment

• Patients with ASA =4

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Device:
• manometer
cuff pressure to be measured with manometer

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi Konuk Training and Research Hospital	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cuff pressure	cuff pressure to be measured with manometer	1 hour