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

Not Applicable

Completed

• Conditions: Thyroid Tumor
• Interventions: Behavioral: Modified intubation protocol; Behavioral: Conventional intubation protocol; Behavioral: Delayed resumption of oral intake; Behavioral: Early resumption of oral intake

• Registration Number: NCT05624463
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2022-11-13
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-22
• Study Start: 2023-04-01
• Primary Completion: 2024-02-06
• Study Completion: 2024-02-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified intubation protocol+delayed resumption of oral intake	Delayed resumption of oral intake	Participants receive modified intubation protocol and delayed resumption of oral intake.
Conventional intubation protocol+delayed resumption of oral intake	Delayed resumption of oral intake	Participants receive conventional intubation protocol and delayed resumption of oral intake.
Modified intubation protocol+early resumption of oral intake	Modified intubation protocol	Participants receive modified intubation protocol and early resumption of oral intake.
Modified intubation protocol+delayed resumption of oral intake	Modified intubation protocol	Participants receive modified intubation protocol and delayed resumption of oral intake.
Modified intubation protocol+early resumption of oral intake	Early resumption of oral intake	Participants receive modified intubation protocol and early resumption of oral intake.
Conventional intubation protocol+early resumption of oral intake	Conventional intubation protocol	Participants receive conventional intubation protocol and early resumption of oral intake.
Conventional intubation protocol+early resumption of oral intake	Early resumption of oral intake	Participants receive conventional intubation protocol and early resumption of oral intake.
Conventional intubation protocol+delayed resumption of oral intake	Conventional intubation protocol	Participants receive conventional intubation protocol and delayed resumption of oral intake.

Primary Outcome Measures

Name	Time	Method
Quality of Recovery-15 score on the first day after surgery	one day	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	through patient discharge, an average of 2-3 days after surgery	Patient satisfaction was assessed based on the postoperative numeric rating scale (NRS) scores, with 0 indicating extreme dissatisfaction and 10 indicating very satisfaction.
Quality of Recovery-15 score on the day of discharge	one day	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.
Postoperative hospital stay length	through patient discharge, an average of 2-3 days after surgery	Postoperative hospital stay length
Drainage volume	through removal of drainage tube, an average of 2 days after surgery	Total drainage volume after operation.
Adverse event	through patient discharge, an average of 2-3 days after surgery	The occurrence of adverse events such as severe choking, reintubation, postoperative bleeding.
Postoperative pain	one day	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.
Postoperative patient discomfort	one day	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.
Intubation time	one day	Time from the end of pre-oxygenation to the completion of intubation and position setted.
Endotracheal tube readjustment rate	one day	Rate of endotracheal tube readjustment caused by the lose or weakness of monitor signal during the surgery.
Postoperative nausea and vomiting	through patient discharge, an average of 2-3 days after surgery	Researchers recorded the occurences and treatments of postoperative nausea and vomiting.
Gastrointestinal recovery time	through exhaustion after surgery, an average of 1-2 days after surgery	The first postoperative exhaustion time recorded was considered as gastrointestinal recovery time.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China