Clinical trial NCT05624463: Effect of Modified Endotracheal Intubation Protocol Combined With Early Oral Intake on Postoperative Recovery Quality in Thyroid and Parathyroid Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Tumor
Keywords: Thyroidectomy
Enhanced Recovery After Surgery
Quality of Recovery-15
Parathyroidectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Recovery-15 score on the first day after surgery
timeFrame: one day
Secondary outcomes:
measure: Quality of Recovery-15 score on the day of discharge
timeFrame: one day
measure: Patient satisfaction
timeFrame: through patient discharge, an average of 2-3 days after surgery
measure: Postoperative pain
timeFrame: one day
measure: Postoperative patient discomfort
timeFrame: one day
measure: Intubation time
timeFrame: one day
measure: Endotracheal tube readjustment rate
timeFrame: one day
measure: Postoperative nausea and vomiting
timeFrame: through patient discharge, an average of 2-3 days after surgery
measure: Gastrointestinal recovery time
timeFrame: through exhaustion after surgery, an average of 1-2 days after surgery
measure: Drainage volume
timeFrame: through removal of drainage tube, an average of 2 days after surgery
measure: Postoperative hospital stay length
timeFrame: through patient discharge, an average of 2-3 days after surgery
measure: Adverse event
timeFrame: through patient discharge, an average of 2-3 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Le Shen, PhD
role: STUDY_CHAIR
References: