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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Thyroid Tumor

Treatments: Behavioral: Delayed resumption of oral intake; Behavioral: Modified intubation protocol; Behavioral: Conventional intubation protocol; Behavioral: Early resumption of oral intake

Study type: Interventional

Funder types: Other

Identifiers

NCT05624463

K-2501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

Modified intubation protocol+early resumption of oral intake

Experimental group

Description:

Participants receive modified intubation protocol and early resumption of oral intake.

Treatment:

Behavioral: Modified intubation protocol

Behavioral: Early resumption of oral intake

Modified intubation protocol+delayed resumption of oral intake

Other group

Description:

Participants receive modified intubation protocol and delayed resumption of oral intake.

Treatment:

Behavioral: Modified intubation protocol

Behavioral: Delayed resumption of oral intake

Conventional intubation protocol+early resumption of oral intake

Other group

Description:

Participants receive conventional intubation protocol and early resumption of oral intake.

Treatment:

Behavioral: Early resumption of oral intake

Behavioral: Conventional intubation protocol

Conventional intubation protocol+delayed resumption of oral intake

Other group

Description:

Participants receive conventional intubation protocol and delayed resumption of oral intake.

Treatment:

Behavioral: Conventional intubation protocol

Behavioral: Delayed resumption of oral intake