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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified intubation protocol+early resumption of oral intake | Experimental | Participants receive modified intubation protocol and early resumption of oral intake. |
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| Modified intubation protocol+delayed resumption of oral intake | Other | Participants receive modified intubation protocol and delayed resumption of oral intake. |
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| Conventional intubation protocol+early resumption of oral intake | Other | Participants receive conventional intubation protocol and early resumption of oral intake. |
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| Conventional intubation protocol+delayed resumption of oral intake | Other | Participants receive conventional intubation protocol and delayed resumption of oral intake. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified intubation protocol | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Le Shen, PhD | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41068829 | Derived | Wu J, Zhang Y, Shen L. Modified versus conventional intubation and early versus delayed oral intake in thyroid surgery: a 2 x 2 factorial randomized controlled trial. Perioper Med (Lond). 2025 Oct 9;14(1):106. doi: 10.1186/s13741-025-00594-w. | |
| 38238052 | Derived | Wu J, Zhang Y, Shen L. 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 randomised controlled trial protocol. BMJ Open. 2024 Jan 18;14(1):e075999. doi: 10.1136/bmjopen-2023-075999. |
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All IPD that underlie results in a publication are to be shared to other researchers.
Starting 6 months after publication, and ending 24 months after publication.
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.
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Randomized controlled trial：Participants who enroll in randomized controlled trials differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By randomly allocating participants among compared treatments, an randomized controlled trial enables statistical control over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an randomized controlled trial may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied.
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The questionnaire collectors and outcomes assessor will not be informed of the group of patients
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| Conventional intubation protocol | Behavioral | 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. |
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| Early resumption of oral intake | Behavioral | 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. |
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| Delayed resumption of oral intake | Behavioral | 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. |
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| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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