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Modified Endotracheal Intubation Procedure and Early Oral Intake.

Primary Purpose

Thyroid Tumor

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified intubation process
Conventional intubation process
Early resumption of oral intake
Late resumption of oral intake
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Tumor focused on measuring Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15, Parathyroidectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 Intraoperative recurrent laryngeal nerve monitoring is required Thyroid or parathyroid surgery 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)

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Other

Other

Arm Label

Modified intubation process+early resumption of oral intake

Modified intubation process+late resumption of oral intake

Conventional intubation process+early resumption of oral intake

Conventional intubation process+late resumption of oral intake

Arm Description

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

Participants receive modified intubation process and late resumption of oral intake.

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

Participants receive conventional intubation process and late resumption of oral intake.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Patient satisfaction
The overall satisfaction of the patients during hospitalization was scored immediately before the patients were discharged from the hospital. The patients were scored according to 0-10 points, 0 being completely dissatisfied and 10 being completely satisfied.
Postoperative pain
The patients were given self-evaluation before the first drinking water and 8 hours after the operation. They were divided into pharyngeal pain and surgical incision pain, which were scored according to 0-10 points respectively. 0 point was completely painless, and 10 point was unbearable pain.
Length of hospital stay
Length of hospital stay
Total drainage volume after operation
Total drainage volume after operation
Postoperative defecation time
Postoperative defecation time
Postoperative exhaustion time
Postoperative exhaustion time
Postoperative nausea and vomiting
Researchers will record the occurences and treatments of postoperative nausea and vomiting
Intubation time
Time from the end of pre-oxygenation to the completion of intubation and position setted.
Endotracheal tube readjustment rate
Rate of endotracheal tube readjustment caused by the lose or weakness of monitor signal during the surgery.

Full Information

First Posted
November 13, 2022
Last Updated
May 26, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05624463
Brief Title
Modified Endotracheal Intubation Procedure and Early Oral Intake.
Official Title
Effect of Modified Endotracheal Intubation Procedure Combined With Early Oral Intake on Postoperative Recovery Quality of Patients Undergoing Intraoperative Recurrent Laryngeal Nerve Monitoring.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Tumor
Keywords
Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15, Parathyroidectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The questionnaire collectors and outcomes assessor will not be informed of the group of patients
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified intubation process+early resumption of oral intake
Arm Type
Experimental
Arm Description
Participants receive modified intubation process and early resumption of oral intake.
Arm Title
Modified intubation process+late resumption of oral intake
Arm Type
Other
Arm Description
Participants receive modified intubation process and late resumption of oral intake.
Arm Title
Conventional intubation process+early resumption of oral intake
Arm Type
Other
Arm Description
Participants receive conventional intubation process and early resumption of oral intake.
Arm Title
Conventional intubation process+late resumption of oral intake
Arm Type
Other
Arm Description
Participants receive conventional intubation process and late resumption of oral intake.
Intervention Type
Behavioral
Intervention Name(s)
Modified intubation process
Intervention Description
Refers to the modified intubation process of recurrent laryngeal nerve monitoring tube published by the applicant on Journal of Clinical Anesthesia. 1. Turn on the 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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional intubation process
Intervention Description
It means that the recurrent laryngeal nerve monitoring tube is intubated according to the intubation method described in the current guidelines. 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.
Intervention Type
Behavioral
Intervention Name(s)
Early resumption of oral intake
Intervention Description
Drink 30-50ml of normal temperature water after meeting the post-anaesthesia care unit transfer out standard. If the patient swallows successfully and does not cough, after returning to the ward, medical personnel of the ward will guide patient to resume drinking and eating early: patient will resume drinking water within one hour after returning to the ward, a small amount of water for several times until the amount of drinking water reaches 300ml. If the patient does not have discomfort symptoms, the patient will resume eating according to normal drinking and eating habits.
Intervention Type
Behavioral
Intervention Name(s)
Late resumption of oral intake
Intervention Description
Drink 30-50ml of normal temperature water after 6h after the operation. A small amount of water can be used several times, and the amount of water can reach 300ml. If the patient does not have any discomfort symptoms, medical personnel can guide the patient to recover diet according to normal drinking and eating habits.
Primary Outcome Measure Information:
Title
Quality of Recovery-15 score on the first day after surgery
Description
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.
Time Frame
one day
Secondary Outcome Measure Information:
Title
Quality of Recovery-15 score on the day of discharge
Description
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.
Time Frame
one day
Title
Patient satisfaction
Description
The overall satisfaction of the patients during hospitalization was scored immediately before the patients were discharged from the hospital. The patients were scored according to 0-10 points, 0 being completely dissatisfied and 10 being completely satisfied.
Time Frame
through patient discharge, an average of 3-4 day
Title
Postoperative pain
Description
The patients were given self-evaluation before the first drinking water and 8 hours after the operation. They were divided into pharyngeal pain and surgical incision pain, which were scored according to 0-10 points respectively. 0 point was completely painless, and 10 point was unbearable pain.
Time Frame
through patient discharge, an average of 3-4 day
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
through patient discharge, an average of 3-4 day
Title
Total drainage volume after operation
Description
Total drainage volume after operation
Time Frame
through removal of drainage tube, an average of 2 day
Title
Postoperative defecation time
Description
Postoperative defecation time
Time Frame
through defecation after surgery, an average of 1-2 day after surgery
Title
Postoperative exhaustion time
Description
Postoperative exhaustion time
Time Frame
through exhaustion after surgery, an average of 1-2 day after surgery
Title
Postoperative nausea and vomiting
Description
Researchers will record the occurences and treatments of postoperative nausea and vomiting
Time Frame
through patient discharge, an average of 3-4 day
Title
Intubation time
Description
Time from the end of pre-oxygenation to the completion of intubation and position setted.
Time Frame
one day
Title
Endotracheal tube readjustment rate
Description
Rate of endotracheal tube readjustment caused by the lose or weakness of monitor signal during the surgery.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Intraoperative recurrent laryngeal nerve monitoring is required Thyroid or parathyroid surgery 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Le Shen, PhD
Phone
13810248138
Email
pumchshenle@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juelun Wu, B.S.
Phone
18707486338
Email
18707486338@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Le Shen, PhD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juelun Wu, B.S.
Phone
18707486338
Email
18707486338@163.com
First Name & Middle Initial & Last Name & Degree
Le Shen, PhD
Phone
13810248138
Email
pumchshenle@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Modified Endotracheal Intubation Procedure and Early Oral Intake.

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