Airway MorbidityNCT02026882
Supreme LMA Use in Urgent Caesarean Section
A study testing Supreme Laryngeal Mask Airway in people with Airway Morbidity, run by QuanZhou Women and Children's Hospital at 1 site in China.
Trial summary
The Supreme Laryngeal Mask Airway (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 elective Caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- Supreme Laryngeal Mask Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to May 2015
- 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
- American Society of Anesthesiology status 1 or 2
- Weight 40 to 75kg
- Normal airway assessment
- Term pregnancy (36 weeks or more)
- Urgent Caesarean Section
Who cannot join
- Body mass index (35 or more)
- Difficult airway (Mallampati 4 or abnormal airway assessment)
- Gastrooesophageal reflux
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supreme Laryngeal Mask Use in Urgent Caesarean Section
The Supreme Laryngeal Mask Airway (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 elective Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents.
The primary study hypothesis is the first attempt insertion success rate of SLMA use in urgent Caesarean section.
Read the detailed description
Investigators propose a prospective cohort study to study the first attempt insertion success rate of supreme LMA in general anaesthesia for urgent caesarean section.
- Conditions
- Airway Morbidity
- Being tested
- Supreme Laryngeal Mask Airway
- Keywords
- Airway, Caesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supreme Laryngeal Mask AirwayDevice
Supreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Supreme Laryngeal Mask Airway | Other | Supreme Laryngeal Mask Airway with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia. Receives: Device: Supreme Laryngeal Mask Airway |
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 withdrawal of the device from the patient's airway
Measured: 1 hour
Secondary outcomes (8)
Time to effective airway placement
Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide waveform
Measured: 1 hour
Aspiration
Signs of aspiration as evidenced by perioperative hypoxaemia, wheezing or crepitations upon auscultation of lungs or postoperative dyspnoea with chest x ray signs of aspiration
Measured: 1 hour
blood on SLMA on removal
inspection for presence of blood upon removal of SLMA
Measured: 1 hour
Sore throat
Sore throat present in recovery room
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 will be recorded.
Measured: 1 hour
Gastric aspirate
Volume of gastric aspirate 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 posted3 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway MorbidityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- QuanZhou Women and Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KK Women's and Children's Hospital
- Responsible party
- Principal investigator, Wei Yu Yao, QuanZhou Women and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026882
- Sponsor's protocol ID
- 2013-11-11
- Status last verified
- Jul 2020
- First submitted
- 31 Dec 2013
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lim MJ, Tan HS, Tan CW, Li SY, Yao WY, Yuan YJ, Sultana R, Sng BL. The effects of labor on airway outcomes with Supreme laryngeal mask in women undergoing cesarean delivery under general anesthesia: a cohort study. BMC Anesthesiol. 2020 Aug 26;20(1):213. doi: 10.1186/s12871-020-01132-5.
PubMed 32847548Tan HS, Li SY, Yao WY, Yuan YJ, Sultana R, Han NR, Sia ATH, Sng BL. Association of Mallampati scoring on airway outcomes in women undergoing general anesthesia with Supreme laryngeal mask airway in cesarean section. BMC Anesthesiol. 2019 Jul 8;19(1):122. doi: 10.1186/s12871-019-0796-5.
PubMed 31286890Li SY, Yao WY, Yuan YJ, Tay WS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Supreme laryngeal mask airway use in general Anesthesia for category 2 and 3 Cesarean delivery: a prospective cohort study. BMC Anesthesiol. 2017 Dec 19;17(1):169. doi: 10.1186/s12871-017-0460-x.
PubMed 29258438
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supreme Laryngeal Mask Use in Urgent Caesarean Section
- ClinicalTrials.gov ID
- NCT02026882
- Acronym / sponsor ID
- 2013-11-11
- Conditions
- Airway Morbidity
- Keywords
- Airway, Caesarean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- QuanZhou Women and Children's HospitalUniversity, hospital or other
- Collaborators
- KK Women's and Children's Hospital
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Jan 2014 (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 Supreme Laryngeal Mask Airway (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 elective Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents.
The primary study hypothesis is the first attempt insertion success rate of SLMA use in urgent Caesarean section.
Detailed description
Investigators propose a prospective cohort study to study the first attempt insertion success rate of supreme LMA in general anaesthesia for urgent caesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supreme Laryngeal Mask Airway | Other | Device: Supreme Laryngeal Mask AirwaySupreme Laryngeal Mask Airway with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 50 years old
- American Society of Anesthesiology status 1 or 2
- Weight 40 to 75kg
- Normal airway assessment
- Term pregnancy (36 weeks or more)
Key exclusion criteria (3 listed)
- Body mass index (35 or more)
- Difficult airway (Mallampati 4 or abnormal airway assessment)
- Gastrooesophageal reflux
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 |
|---|---|---|
| Supreme Laryngeal Mask AirwaySupreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia. | Device | Supreme Laryngeal Mask Airway |
Primary outcome
First attempt insertion success rate
Time frame: 1 hour
An attempt is defined as insertion and withdrawal of the device from the patient's airway
8 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
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 3 Aug 2020.
- Derived from this study: PubMed 32847548Lim MJ, Tan HS, Tan CW, Li SY, Yao WY, Yuan YJ, Sultana R, Sng BL. The effects of labor on airway outcomes with Supreme laryngeal mask in women undergoing cesarean delivery under general anesthesia: a cohort study. BMC Anesthesiol. 2020 Aug 26;20(1):213. doi: 10.1186/s12871-020-01132-5.
- Derived from this study: PubMed 31286890Tan HS, Li SY, Yao WY, Yuan YJ, Sultana R, Han NR, Sia ATH, Sng BL. Association of Mallampati scoring on airway outcomes in women undergoing general anesthesia with Supreme laryngeal mask airway in cesarean section. BMC Anesthesiol. 2019 Jul 8;19(1):122. doi: 10.1186/s12871-019-0796-5.
- Derived from this study: PubMed 29258438Li SY, Yao WY, Yuan YJ, Tay WS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Supreme laryngeal mask airway use in general Anesthesia for category 2 and 3 Cesarean delivery: a prospective cohort study. BMC Anesthesiol. 2017 Dec 19;17(1):169. doi: 10.1186/s12871-017-0460-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supreme Laryngeal Mask Airway in people with Airway Morbidity, run by QuanZhou Women and Children's 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 6 inclusion and 3 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 3 Aug 2020. 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?
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 NCT02026882, which also lists 3 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 3 Aug 2020.