Thyroid TumorNCT05624463
Effect of Modified Endotracheal Intubation Protocol Combined With Early Oral Intake on Postoperative Recovery Quality in Thyroid and Parathyroid Surgery
A study testing Modified intubation protocol, Conventional intubation protocol and Early resumption of oral intake in people with Thyroid Tumor, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Tumor
- What is being tested?
- Modified intubation protocol, Conventional intubation protocol and Early resumption of oral intake
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Thyroid Tumor
- Being tested
- Modified intubation protocol, Conventional intubation protocol, Early resumption of oral intake, Delayed resumption of oral intake
- Keywords
- Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15, Parathyroidectomy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified intubation protocolBehavioural
- 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 protocolBehavioural
- 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 intakeBehavioural
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 intakeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified intubation protocol+early resumption of oral intake | Experimental | Participants receive modified intubation protocol and early resumption of oral intake. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Conventional intubation protocol; Behavioral: Delayed resumption of oral intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (11)
Quality of Recovery-15 score on the day of discharge
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.
Measured: one day
Patient satisfaction
Patient satisfaction was assessed based on the postoperative numeric rating scale (NRS) scores, with 0 indicating extreme dissatisfaction and 10 indicating very satisfaction.
Measured: through patient discharge, an average of 2-3 days after surgery
Postoperative pain
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.
Measured: one day
Postoperative patient discomfort
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.
Measured: one day
Intubation time
Time from the end of pre-oxygenation to the completion of intubation and position setted.
Measured: one day
Endotracheal tube readjustment rate
Rate of endotracheal tube readjustment caused by the lose or weakness of monitor signal during the surgery.
Measured: one day
Postoperative nausea and vomiting
Researchers recorded the occurences and treatments of postoperative nausea and vomiting.
Measured: through patient discharge, an average of 2-3 days after surgery
Gastrointestinal recovery time
The first postoperative exhaustion time recorded was considered as gastrointestinal recovery time.
Measured: through exhaustion after surgery, an average of 1-2 days after surgery
Drainage volume
Total drainage volume after operation.
Measured: through removal of drainage tube, an average of 2 days after surgery
Postoperative hospital stay length
Postoperative hospital stay length
Measured: through patient discharge, an average of 2-3 days after surgery
Adverse event
The occurrence of adverse events such as severe choking, reintubation, postoperative bleeding.
Measured: through patient discharge, an average of 2-3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Apr 2023
- Primary completion6 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid TumorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Le Shen, PhD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624463
- Sponsor's protocol ID
- K-2501
- Status last verified
- Mar 2024
- First submitted
- 13 Nov 2022
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication are to be shared to other researchers.
Publications
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.
PubMed 41068829Wu 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.
PubMed 38238052
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05624463
- Acronym / sponsor ID
- K-2501
- Conditions
- Thyroid Tumor
- Keywords
- Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15, Parathyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Modified intubation protocol+early resumption of oral intake | Experimental | Behavioral: Modified intubation protocol, Behavioral: Early resumption of oral intakeParticipants receive modified intubation protocol and early resumption of oral intake. |
| Modified intubation protocol+delayed resumption of oral intake | Other | Behavioral: Modified intubation protocol, Behavioral: Delayed resumption of oral intakeParticipants receive modified intubation protocol and delayed resumption of oral intake. |
| Conventional intubation protocol+early resumption of oral intake | Other | Behavioral: Conventional intubation protocol, Behavioral: Early resumption of oral intakeParticipants receive conventional intubation protocol and early resumption of oral intake. |
| Conventional intubation protocol+delayed resumption of oral intake | Other | Behavioral: Conventional intubation protocol, Behavioral: Delayed resumption of oral intakeParticipants receive conventional intubation protocol and delayed resumption of oral intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified intubation protocol1. 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. | Behavioural | Modified intubation protocol+delayed resumption of oral intake, Modified intubation protocol+early resumption of oral intake |
| Conventional intubation protocol1. 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. | Behavioural | Conventional intubation protocol+delayed resumption of oral intake, Conventional intubation protocol+early resumption of oral intake |
| Early resumption of oral intakePatients 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. | Behavioural | Conventional intubation protocol+early resumption of oral intake, Modified intubation protocol+early resumption of oral intake |
| Delayed resumption of oral intakePatients 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. | Behavioural | Conventional intubation protocol+delayed resumption of oral intake, Modified intubation protocol+delayed resumption of oral intake |
Primary outcome
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.
11 secondary outcomes
Quality of Recovery-15 score on the day of discharge
Time frame: one day
Patient satisfaction
Time frame: through patient discharge, an average of 2-3 days after surgery
Postoperative pain
Time frame: one day
Postoperative patient discomfort
Time frame: one day
Intubation time
Time frame: one day
Endotracheal tube readjustment rate
Time frame: one day
Postoperative nausea and vomiting
Time frame: through patient discharge, an average of 2-3 days after surgery
Gastrointestinal recovery time
Time frame: through exhaustion after surgery, an average of 1-2 days after surgery
Drainage volume
Time frame: through removal of drainage tube, an average of 2 days after surgery
Postoperative hospital stay length
Time frame: through patient discharge, an average of 2-3 days after surgery
Adverse event
Time frame: through patient discharge, an average of 2-3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Derived from this study: PubMed 41068829Wu 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.
- Derived from this study: PubMed 38238052Wu 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication are to be shared to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Le Shen, PhD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified intubation protocol, Conventional intubation protocol and Early resumption of oral intake in people with Thyroid Tumor, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 score on the first day after surgery (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05624463, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.