Complications; Cesarean SectionNCT01858467
Supreme LMA and Endotracheal Intubation Use in Caesarean Section
A study testing Endotracheal intubation and Supreme Laryngeal Mask Airway in people with Complications; Cesarean Section, run by Wei Yu Yao.
Trial summary
The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low-risk patients undergoing Caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- Endotracheal intubation and Supreme Laryngeal Mask Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jul 2014
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 50 years old
- ASA 1 or 2
- Fasted at least 6 hours
- Weight 40 to 75kg
- Normal airway assessment
- Singleton term pregnancy (>36weeks)
- Elective Caesarean section
Who cannot join
- In labour
- Body mass index >35
- Difficult airway (Mallampati 4 or abnormal airway assessment)
- Gastrooesophageal reflux disease
About this study
Official title: Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial
The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low-risk patients undergoing Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The current practice is to use endotracheal intubation with rapid sequence induction in general anaesthesia for Caesarean section.
The primary study hypothesis is the first attempt insertion success rate of SLMA and endotracheal intubation are equivalent with a difference of less than 3%.
Read the detailed description
We propose a randomised controlled trial to study the first attempt insertion success rate of supreme LMA versus endotracheal intubation in general anaesthesia for elective Caesarean section.
- Conditions
- Complications; Cesarean Section
- Being tested
- Endotracheal intubation, Supreme Laryngeal Mask Airway
- Keywords
- Airway, Cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationDevice
Portex endotracheal tube 6.5mm or 7.0mm internal diameter
Supreme Laryngeal Mask AirwayDevice
Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.
| Study group | Role | What they receive |
|---|---|---|
| Supreme Laryngeal Mask Airway | Experimental | Supreme Laryngeal Mask Airway (Airway Device) with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane. Receives: Device: Supreme Laryngeal Mask Airway |
| Endotracheal Intubation | Active comparator | Endotracheal intubation (Airway Device) using Macintosh Laryngoscope with tracheal tube with gastric tube insertion after placement. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane. Receives: Device: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt insertion success rate
An attempt is defined as insertion and complete withdrawal of the device from the patient's airway
Measured: 1 hour
Secondary outcomes (9)
Time to effective airway placement
Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide wave form
Measured: 1 hour
Aspiration
Signs of aspiration as evidenced by perioperative hypoxemia, wheezing or crepitations upon auscultation of lungs or postoperative dyspnea with chest x ray signs of aspiration
Measured: 1 hour
blood on SLMA on removal
inspection for presence of blood on Supreme Laryngeal Mask Airway on removal
Measured: 1 hour
Sore Throat
Sore throat present in the postanaesthesia care unit
Measured: 1 hour
Patient satisfaction
Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%)
Measured: 1 hour
Regurgitation
Gastric contents identified in the mouth with pH less than 4
Measured: 1 hour
Seal pressure
Recorded by closing the adjustable pressure limiting valve and insufflating the closed breathing system with 3L/min fresh gas flow. The peak circuit airway pressure achieved was recorded.
Measured: 1 hour
Gastric aspirate
Volume of gastric aspiration using gastric tube and pH of gastric aspirate using litmus paper
Measured: 1 hour
Neonatal outcomes
Neonatal birthweight. APGAR score. Umbilical venous cord pH.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionJul 2014
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 Complications; Cesarean SectionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Yu Yao
- Sponsor type
- University, hospital or other
- Collaborators
- KK Women's and Children's Hospital
- Responsible party
- Sponsor-investigator, Wei Yu Yao, QuanZhou Women and Children's Hospital
- Investigators
- Shi Y Li, MD, Study director, QuanZhou Women and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858467
- Sponsor's protocol ID
- 2012-10-27
- Status last verified
- May 2018
- First submitted
- 7 Apr 2013
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yao WY, Li SY, Yuan YJ, Tan HS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Comparison of Supreme laryngeal mask airway versus endotracheal intubation for airway management during general anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2019 Jul 8;19(1):123. doi: 10.1186/s12871-019-0792-9.
PubMed 31286883
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01858467
- Acronym / sponsor ID
- 2012-10-27
- Conditions
- Complications; Cesarean Section
- Keywords
- Airway, Cesarean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- Wei Yu YaoUniversity, hospital or other
- Collaborators
- KK Women's and Children's Hospital
- Study start
- May 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 May 2013 (estimated)
- 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 LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low-risk patients undergoing Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The current practice is to use endotracheal intubation with rapid sequence induction in general anaesthesia for Caesarean section.
The primary study hypothesis is the first attempt insertion success rate of SLMA and endotracheal intubation are equivalent with a difference of less than 3%.
Detailed description
We propose a randomised controlled trial to study the first attempt insertion success rate of supreme LMA versus endotracheal intubation in general anaesthesia for elective Caesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supreme Laryngeal Mask Airway | Experimental | Device: Supreme Laryngeal Mask AirwaySupreme Laryngeal Mask Airway (Airway Device) with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane. |
| Endotracheal Intubation | Active comparator | Device: Endotracheal intubationEndotracheal intubation (Airway Device) using Macintosh Laryngoscope with tracheal tube with gastric tube insertion after placement. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 to 50 years old
- ASA 1 or 2
- Fasted at least 6 hours
- Weight 40 to 75kg
- Normal airway assessment
Key exclusion criteria (4 listed)
- In labour
- Body mass index >35
- Difficult airway (Mallampati 4 or abnormal airway assessment)
- Gastrooesophageal reflux disease
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 |
|---|---|---|
| Endotracheal intubationPortex endotracheal tube 6.5mm or 7.0mm internal diameter | Device | Endotracheal Intubation |
| Supreme Laryngeal Mask AirwaySupreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion. | Device | Supreme Laryngeal Mask Airway |
Primary outcome
First attempt insertion success rate
Time frame: 1 hour
An attempt is defined as insertion and complete withdrawal of the device from the patient's airway
9 secondary outcomes
Time to effective airway placement
Time frame: 1 hour
Aspiration
Time frame: 1 hour
blood on SLMA on removal
Time frame: 1 hour
Sore Throat
Time frame: 1 hour
Patient satisfaction
Time frame: 1 hour
Regurgitation
Time frame: 1 hour
Seal pressure
Time frame: 1 hour
Gastric aspirate
Time frame: 1 hour
Neonatal outcomes
Time frame: 1 hour
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 7 May 2018.
- Derived from this study: PubMed 31286883Yao WY, Li SY, Yuan YJ, Tan HS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Comparison of Supreme laryngeal mask airway versus endotracheal intubation for airway management during general anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2019 Jul 8;19(1):123. doi: 10.1186/s12871-019-0792-9.
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The Mepilex Cesarean Delivery Trial / MEPIDEL
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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.
Shi Y Li, MD study director
QuanZhou Women and Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation and Supreme Laryngeal Mask Airway in people with Complications; Cesarean Section, run by Wei Yu Yao.
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 7 inclusion and 4 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
First attempt insertion success rate (time frame: 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 NCT01858467, 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 7 May 2018.