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

NCT05624463 | Completed DMC

• 1 other identifier: K-2501
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Tumor

Keywords

Thyroidectomy; Enhanced Recovery After Surgery; Quality of Recovery-15; Parathyroidectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Quality of Recovery-15 score on the day of discharge

  one day

• Patient satisfaction

  through patient discharge, an average of 2-3 days after surgery

• Postoperative pain

  one day

• Postoperative patient discomfort

  one day

• Intubation time

  one day

Study Arms (4)

Modified intubation protocol+early resumption of oral intake

EXPERIMENTAL

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

Behavioral: Modified intubation protocol; Behavioral: Early resumption of oral intake

Modified intubation protocol+delayed resumption of oral intake

OTHER

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

Behavioral: Modified intubation protocol; Behavioral: Delayed resumption of oral intake

Conventional intubation protocol+early resumption of oral intake

OTHER

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

Behavioral: Conventional intubation protocol; Behavioral: Early resumption of oral intake

Conventional intubation protocol+delayed resumption of oral intake

OTHER

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

Behavioral: Conventional intubation protocol; Behavioral: Delayed resumption of oral intake

Interventions

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.

Modified intubation protocol+delayed resumption of oral intake; Modified intubation protocol+early resumption of oral intake

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.

Conventional intubation protocol+delayed resumption of oral intake; Conventional intubation protocol+early resumption of oral intake

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.

Conventional intubation protocol+early resumption of oral intake; Modified intubation protocol+early resumption of oral intake

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.

Conventional intubation protocol+delayed resumption of oral intake; Modified intubation protocol+delayed resumption of oral intake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (2)

• 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.

  PMID: 41068829 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.

  PMID: 38238052 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Le Shen, PhD

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The questionnaire collectors and outcomes assessor will not be informed of the group of patients
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 22, 2022
• Study Start: April 1, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 9, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication, and ending 24 months after publication.
• Access Criteria: 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.

Locations

CN (1)