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

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Tumor
• Intervention / Treatment: Behavioral: Modified intubation protocol; Behavioral: Early resumption of oral intake; Behavioral: Delayed resumption of oral intake; Behavioral: Conventional intubation protocol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified intubation protocol+early resumption of oral intake; Participants receive modified intubation protocol and early resumption of oral intake.	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.; Behavioral: 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.
Other: Modified intubation protocol+delayed resumption of oral intake; Participants receive modified intubation protocol and delayed resumption of oral intake.	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.; Behavioral: 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.
Other: Conventional intubation protocol+early resumption of oral intake; Participants receive conventional intubation protocol and early resumption of oral intake.	Behavioral: 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.; Behavioral: 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.
Other: Conventional intubation protocol+delayed resumption of oral intake; Participants receive conventional intubation protocol and delayed resumption of oral intake.	Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Intubation time	Time from the end of pre-oxygenation to the completion of intubation and position setted.	one day
Endotracheal tube readjustment rate	Rate of endotracheal tube readjustment caused by the lose or weakness of monitor signal during the surgery.	one day
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
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
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
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
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
Drainage volume	Total drainage volume after operation.	through removal of drainage tube, an average of 2 days after surgery
Postoperative hospital stay length	Postoperative hospital stay length	through patient discharge, an average of 2-3 days after surgery
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Le Shen, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Enhanced Recovery After Surgery; Thyroidectomy; Parathyroidectomy; Quality of Recovery-15
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: K-2501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication are to be shared to other researchers.
• IPD Sharing Time Frame: Starting 6 months after publication, and ending 24 months after publication.
• IPD Sharing Access Criteria: Researchers may apply for IPD after data access proposal was approved by Research Ethics Committee of PUMCH. IPD can be used for meta-analysis of individual participant data. Data access proposal should be sent to pumchshenle@163.com, and IPD will be returned to the applicants.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No