Laparoscopic SurgeryNCT05338827
Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM
A study testing Polyvinyl Chloride Tube group and Wire-Reinforced Tube group in people with Laparoscopic Surgery, run by Qianfoshan Hospital at 1 site in China.
Trial summary
To compare a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway, to observe the success rate of intubation and the incidence of postoperative adverse reactions, and to explore the best type of endotracheal tube through the SaCoVLM video laryngeal… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- Polyvinyl Chloride Tube group and Wire-Reinforced Tube group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Aug 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to accept elective laparoscopic surgery under general anaesthesia.
- Aged 18-70 years.
- Body mass index (BMI) 18.5-27.9 kg/m2.
- ASA class I-III.
Who cannot join
- Neurological or psychiatric diseases (such as schizophrenia and depression), or unconscious.
- Severe cardiopulmonary dysfunction.
- Vocal cord injury, pharyngeal disease or history of neck surgery.
- Risk of reflux aspiration and indwelling nasogastric tube before and after surgery.
- Mouth opening less than 2 cm, limitation of cervical extension, modified Mallampati score IV.
- SaCoVLM glottic exposure grade 3 or 4.
- Participated in other clinical studies during the last 3 months.
- Refused to give informed consent for the clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yongtao Sun
Jinan, Shandong, 250000
Yongtao Sun, doctor, 18660795201, sunyongtao1979@163.com
About this study
Official title: Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM Video Laryngeal Mask Airway: a Randomized Controlled Study
To compare a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway, to observe the success rate of intubation and the incidence of postoperative adverse reactions, and to explore the best type of endotracheal tube through the SaCoVLM video laryngeal mask airway, so as to provide reference for its clinical application.
Read the detailed description
- At present, there are few studies on intubation through SaCoVLM video laryngeal mask airway. It is proposed that endotracheal intubation through SaCoVLM video laryngeal mask airway is to verify its feasibility.
- The purpose is to explore the best type of endotracheal tube by observing the success rate of intubation through SaCoVLM video laryngeal mask airway and the incidence of postoperative adverse reactions.
- By observing the hemodynamic changes of the polyvinyl chloride tubes and the wire-reinforced tube during intubation through SaCoVLM video laryngeal mask airway , the effects of the two tracheal tubes on the hemodynamics of patients were compared.
- By observing the optimized operation which can improve the success rate of tracheal intubation in the experiment, it can be better applied in clinical practice.
- Conditions
- Laparoscopic Surgery
- Being tested
- Polyvinyl Chloride Tube group, Wire-Reinforced Tube group
- Keywords
- SaCO Video Laryngeal Mask Airway, intubating laryngeal mask airway, laryngeal mask airway, supraglottic airway devices, endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyvinyl Chloride Tube groupProcedure or surgery
The anaesthesiologist will perform a visual screen for the SaCoVLM glottic exposure grade after the SaCoVLM is successfully inserted. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.
Wire-Reinforced Tube groupProcedure or surgery
The anaesthesiologist will perform a visual screen for the SaCoVLM glottic exposure grade after the SaCoVLM is successfully inserted. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Polyvinyl Chloride Tube group | Experimental | The PVC tube used is a stiff tube with an anterior curvature of approximately 130°, which retains the additional curvature imposed by its passage through the ventilation conduit of the ILMA. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded. Receives: Procedure: Polyvinyl Chloride Tube group |
| Wire-Reinforced Tube group | Experimental | In contrast to the PVC tube, the WR tube is flexible with a slightly anterior curvature. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded. Receives: Procedure: Wire-Reinforced Tube group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total success rate of tracheal intubation
defined as the cumulative third-attempt intubation success rate
Measured: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to half hour or 1 hour.
Secondary outcomes (7)
Successful insertion rate on the first attempt
tracheal intubation is considered successful if the endotracheal tube slides through the LMA without any resistance, and tracheal intubation was confirmed by the laryngeal mask visual screen and detection of end-tidal carbon dioxide (CO2).
Measured: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Time of tracheal intubation
defined as the time from picking up the tracheal tube to the appearance of three standard end-tidal CO2 waveforms on the monitor.
Measured: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Site of first contact of tracheal intubation
which will be identified with the SaCoVLM visual screen (four areas are defined based on the glottic opening: the interarytenoid fold, the left and right aryepiglottic, the vestibular and vocal folds, and the tubercle of the epiglottis).8
Measured: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Adjustment action for tracheal intubation
if tracheal intubation is unsuccessful after the first attempt, the tube will be pulled 2 cm, rotated and then advanced. If this attempt is unsuccessful, the tube will again be pulled 2 cm, adjusted to the SaCoVLM by the up-down manoeuvre, rotated and then advanced. If tracheal intubation is accomplished after either manoeuvre, this is considered a success and the manoeuvre used would be documented.
Measured: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Haemodynamic fluctuation
the systolic and diastolic blood pressure, mean arterial pressure and HR after induction, immediately, and 3 min after insertion of the laryngeal mask; immediately and 3 min after tracheal intubation; 3 min before extubation; and immediately and 3 min after extubation are recorded.
Measured: It will take up to half hour or 1 hour.
Incidence of trauma as evidenced by blood
incidence of trauma as evidenced by blood on ILMA or endotracheal tube after removal
Measured: It will take up to half hour or 1 hour.
Incidence rate of postoperative sore throat, hoarseness and dysphagia at 24 hours after the surgery
the severity of sore throat will be evaluated using a numerical rating scale (0=no sore throat, 10=worst sore throat imaginable). Hoarseness will be classified as mild, moderate or severe (overall dysphonia grade, roughness, breathiness, asthenia and strain score). Dysphagia will be classified as normal, mild, moderate or severe according to the severity.
Measured: one day after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 May 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongtao Sun, Qianfoshan Hospital
- Investigators
- Yongtao Sun, doctor, Principal investigator, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338827
- Sponsor's protocol ID
- SaCoVLM
- Status last verified
- Jan 2023
- First submitted
- 14 Apr 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao Z, Guo Y, Gao X, Wang W, Zhang M, Liu MJ, Chen L, Liu Y, Zhang X, Sun Y, Wang Y. Comparison of a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway: protocol for a randomised controlled study. BMJ Open. 2022 Dec 14;12(12):e066084. doi: 10.1136/bmjopen-2022-066084.
PubMed 36517088
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM Video Laryngeal Mask Airway: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05338827
- Acronym / sponsor ID
- SaCoVLM
- Conditions
- Laparoscopic Surgery
- Keywords
- SaCO Video Laryngeal Mask Airway, intubating laryngeal mask airway, laryngeal mask airway, supraglottic airway devices, endotracheal intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 21 Apr 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.
To compare a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway, to observe the success rate of intubation and the incidence of postoperative adverse reactions, and to explore the best type of endotracheal tube through the SaCoVLM video laryngeal mask airway, so as to provide reference for its clinical application.
Detailed description
- At present, there are few studies on intubation through SaCoVLM video laryngeal mask airway. It is proposed that endotracheal intubation through SaCoVLM video laryngeal mask airway is to verify its feasibility.
- The purpose is to explore the best type of endotracheal tube by observing the success rate of intubation through SaCoVLM video laryngeal mask airway and the incidence of postoperative adverse reactions.
- By observing the hemodynamic changes of the polyvinyl chloride tubes and the wire-reinforced tube during intubation through SaCoVLM video laryngeal mask airway , the effects of the two tracheal tubes on the hemodynamics of patients were compared.
- By observing the optimized operation which can improve the success rate of tracheal intubation in the experiment, it can be better applied in clinical practice.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyvinyl Chloride Tube group | Experimental | Procedure: Polyvinyl Chloride Tube groupThe PVC tube used is a stiff tube with an anterior curvature of approximately 130°, which retains the additional curvature imposed by its passage through the ventilation conduit of the ILMA. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded. |
| Wire-Reinforced Tube group | Experimental | Procedure: Wire-Reinforced Tube groupIn contrast to the PVC tube, the WR tube is flexible with a slightly anterior curvature. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to accept elective laparoscopic surgery under general anaesthesia.
- Aged 18-70 years.
- Body mass index (BMI) 18.5-27.9 kg/m2.
- ASA class I-III.
Key exclusion criteria (8 listed)
- Neurological or psychiatric diseases (such as schizophrenia and depression), or unconscious.
- Severe cardiopulmonary dysfunction.
- Vocal cord injury, pharyngeal disease or history of neck surgery.
- Risk of reflux aspiration and indwelling nasogastric tube before and after surgery.
- Mouth opening less than 2 cm, limitation of cervical extension, modified Mallampati score IV.
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 |
|---|---|---|
| Polyvinyl Chloride Tube groupThe anaesthesiologist will perform a visual screen for the SaCoVLM glottic exposure grade after the SaCoVLM is successfully inserted. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded. | Procedure or surgery | Polyvinyl Chloride Tube group |
| Wire-Reinforced Tube groupThe anaesthesiologist will perform a visual screen for the SaCoVLM glottic exposure grade after the SaCoVLM is successfully inserted. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded. | Procedure or surgery | Wire-Reinforced Tube group |
Primary outcome
The total success rate of tracheal intubation
Time frame: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to half hour or 1 hour.
defined as the cumulative third-attempt intubation success rate
7 secondary outcomes
Successful insertion rate on the first attempt
Time frame: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Time of tracheal intubation
Time frame: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Site of first contact of tracheal intubation
Time frame: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Adjustment action for tracheal intubation
Time frame: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.
Haemodynamic fluctuation
Time frame: It will take up to half hour or 1 hour.
Incidence of trauma as evidenced by blood
Time frame: It will take up to half hour or 1 hour.
Incidence rate of postoperative sore throat, hoarseness and dysphagia at 24 hours after the surgery
Time frame: one day after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 36517088Gao Z, Guo Y, Gao X, Wang W, Zhang M, Liu MJ, Chen L, Liu Y, Zhang X, Sun Y, Wang Y. Comparison of a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway: protocol for a randomised controlled study. BMJ Open. 2022 Dec 14;12(12):e066084. doi: 10.1136/bmjopen-2022-066084.
- Individual participant dataSharing planned: No
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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.
Yongtao Sun, doctor principal investigator
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyvinyl Chloride Tube group and Wire-Reinforced Tube group in people with Laparoscopic Surgery, run by Qianfoshan 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 8 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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongtao Sun, doctor (18660795201, sunyongtao1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total success rate of tracheal intubation (time frame: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to half hour or 1 hour.). 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 NCT05338827, which also lists 1 linked publication.
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 2 Feb 2023.