Thyroid Tumor
Conditions
Keywords
Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15, Parathyroidectomy
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.
Interventions
BEHAVIORALModified 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.
BEHAVIORALConventional 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.
BEHAVIORALEarly 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.
BEHAVIORALDelayed 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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The questionnaire collectors and outcomes assessor will not be informed of the group of patients
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Drainage volume | through removal of drainage tube, an average of 2 days after surgery | Total drainage volume after operation. |
| Postoperative hospital stay length | through patient discharge, an average of 2-3 days after surgery | Postoperative hospital stay length |
| 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 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. |
Countries
China
Outcome results
None listed