Effect of Modified Endotracheal Intubation Protocol Combined With Early Oral Intake on Postoperative Recovery Quality in Thyroid and Parathyroid Surgery

Thyroid Tumor Clinical Trial

Official title:

Effect of Modified Endotracheal Intubation Protocol Combined With Early Oral Intake on Postoperative Recovery Quality in Thyroid and Parathyroid Surgery at a Tertiary Hospital in China: A 2x2 Factorial Randomized Controlled Trial Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05624463
• Other study ID #: K-2501
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: February 9, 2024

Study information

• Verified date: March 2024
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of modified endotracheal intubation procedure combined with early oral intake on postoperative recovery quality of patients, so as to further optimize the ERAS（enhanced recovery after surgery） program for thyroid or parathyroid surgery.

Description:

After being informed about the study and potential risk, all patients giving written informed consent will undergo a screening-period to determine eligibility for study entry. Before operation, patients will be randomly assigned to conventional intubation process group or modified intubation process group before the operation. After the operation, patients will enter the PACU（post-anaesthesia care unit） for further observation. When the anesthesiologists and surgeons agree that patients have no early oral drinking high-risk factors, patients will be randomly assigned to early resumption of oral intake group or late resumption of oral intake group for further observation and evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 9, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18

• American Society of Anesthesiologists (ASA) physical status classification I-II

• Body mass index 18.5-29.9kg/m2

• First operation on operation day

Exclusion Criteria:

• Patients or family members cannot understand the conditions and objectives of this study

• Preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high risk of aspiration

• The surgeons or anesthesiologists point out that the patient is not suitable for early postoperative drinking (such as considering the injury of recurrent laryngeal nerve or lymphatic vessels during the operation)

• Patients who cannot be intubated under visual laryngoscope(such as difficult airway, loose incisors and so on)

• Exclusion criteria of Quality of Recovery-15* (*Quality of Recovery-15 exclusion criteria: 1. Unable to understand words and language; 2. Difficult to cooperate due to mental disorders; 3. History of alcohol or drug abuse; 4. Any serious pre-existing medical condition that can limit the objective evaluation after surgery; 5. Any life-threatening complications; 6. Emergency surgery)

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Tumor

Intervention

Behavioral:
• Modified intubation protocol
1. Turn on the electromyography (EMG) monitor and connect the EMG monitor to the patient as the patient is anesthetized; 2. View the vocal cords with video laryngoscope and intubate the patient with the EMG endotracheal tube; 3. Check the EMG monitor to confirm the correct contact between the electrodes and vocal cords; 4. Adjust the tube to achieve proper and stable contact between the electrodes and vocal cords; 5. Tape the EMG endotracheal tube at the midline and position the patient.
• Conventional intubation protocol
1. Intubate the patient with the EMG endotracheal tube and note depth; 2. Position patient and verify the position via Glottic Exam or Respiratory Variation; 3. Fix tube position.
• Early resumption of oral intake
Patients will drink 30-50ml of normal temperature water after Steward scores = 4 at PACU. If patients swallow successfully and have no significant discomfort symptoms, physicians will guide patients to resume drinking and eating gradually.
• Delayed resumption of oral intake
Patients will resume drinking water 6h after the operation at ward. Before patients resume oral drinking, they will be provided 10ml/kg 5% glucose saline intravenously.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery-15 score on the first day after surgery	Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the Quality of Recovery-15 score of the patient.	one day
Secondary	Quality of Recovery-15 score on the day of discharge	Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the Quality of Recovery-15 score of the patient.	one day
Secondary	Patient satisfaction	Patient satisfaction was assessed based on the postoperative numeric rating scale (NRS) scores, with 0 indicating extreme dissatisfaction and 10 indicating very satisfaction.	through patient discharge, an average of 2-3 days after surgery
Secondary	Postoperative pain	The patients were given self-evaluation before resuming oral intake and one day after the surgery. Pharyngeal pain and surgical incision pain were assesed by a visual analogue scale (VAS), with 0 indicating no pain and 10 indicating the worst pain.	one day
Secondary	Postoperative patient discomfort	The postoperative patient discomfort included the feeling of thirst and hunger. The patients were given self-evaluation before surgery and before resuming oral intake after surgery. The discomfort feelings were assesed by a visual analogue scale (VAS), with 0 indicating no discomfort and 10 indicating the worst discomfort.	one day
Secondary	Intubation time	Time from the end of pre-oxygenation to the completion of intubation and position setted.	one day
Secondary	Endotracheal tube readjustment rate	Rate of endotracheal tube readjustment caused by the lose or weakness of monitor signal during the surgery.	one day
Secondary	Postoperative nausea and vomiting	Researchers recorded the occurences and treatments of postoperative nausea and vomiting.	through patient discharge, an average of 2-3 days after surgery
Secondary	Gastrointestinal recovery time	The first postoperative exhaustion time recorded was considered as gastrointestinal recovery time.	through exhaustion after surgery, an average of 1-2 days after surgery
Secondary	Drainage volume	Total drainage volume after operation.	through removal of drainage tube, an average of 2 days after surgery
Secondary	Postoperative hospital stay length	Postoperative hospital stay length	through patient discharge, an average of 2-3 days after surgery
Secondary	Adverse event	The occurrence of adverse events such as severe choking, reintubation, postoperative bleeding.	through patient discharge, an average of 2-3 days after surgery