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NCT Number: NCT05624463

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Modified intubation protocol

Behavioral
  • 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.

Conventional intubation protocol

Behavioral
  • 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.

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.

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.

Primary outcomes

  1. Quality of Recovery-15 score on the first day after surgery

    Time frame: 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 outcomes

  1. Quality of Recovery-15 score on the day of discharge

    Time frame: 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.

  2. Patient satisfaction

    Time frame: 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.

  3. Postoperative pain

    Time frame: 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.

  4. Postoperative patient discomfort

    Time frame: 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.

  5. Intubation time

    Time frame: one day

    Time from the end of pre-oxygenation to the completion of intubation and position setted.

  6. Endotracheal tube readjustment rate

    Time frame: one day

    Rate of endotracheal tube readjustment caused by the lose or weakness of monitor signal during the surgery.

  7. Postoperative nausea and vomiting

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

    Researchers recorded the occurences and treatments of postoperative nausea and vomiting.

  8. Gastrointestinal recovery time

    Time frame: through exhaustion after surgery, an average of 1-2 days after surgery

    The first postoperative exhaustion time recorded was considered as gastrointestinal recovery time.

  9. Drainage volume

    Time frame: through removal of drainage tube, an average of 2 days after surgery

    Total drainage volume after operation.

  10. Postoperative hospital stay length

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

    Postoperative hospital stay length

  11. Adverse event

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

    The occurrence of adverse events such as severe choking, reintubation, postoperative bleeding.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 22, 2022
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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