Laryngeal MasksNCT02618525
Supraorbital Pressure Versus Jaw Thrust for Assessing the Adequate Depth of Anesthesia for LMA Insertion in Children
A study testing Supraorbital pressure and Jaw thrust maneuver in people with Laryngeal Masks, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
BACKGROUND AND OBJECTIVES The purpose of this study is to assess whether the loss of motor response to supraorbital pressure can be an alternative to that of jaw thrust to predict optimal condition for laryngeal mask airway (LMA) insertion in children. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Masks
- What is being tested?
- Supraorbital pressure and Jaw thrust maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNepal
- Study dates
- Feb 2016to Sep 2017
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA physical status 1 and 2
Who cannot join
- Congenital, acute or chronic heart and lung disease, Skull fracture or orbital fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Supraorbital Pressure and Jaw Thrust as Indicators for Depth of Anesthesia for Laryngeal Mask Airway Insertion in Children
BACKGROUND AND OBJECTIVES
The purpose of this study is to assess whether the loss of motor response to supraorbital pressure can be an alternative to that of jaw thrust to predict optimal condition for laryngeal mask airway (LMA) insertion in children.
METHODOLOGY
Fifty children (ASA I-II), aged 2 to 10 years, scheduled to receive general anesthesia that required LMA insertion were randomized to receive either supraorbital pressure (SOP) (n = 25) or jaw thrust (JT) (n = 25), after the loss of verbal response and body movements with a standard anesthetic. When motor response to the study intervention was absent, the LMA was inserted.
Read the detailed description
The investigators enrolled fifty consecutive participants (aged one to ten years) with ASA physical status I or II scheduled to receive general anesthesia for various surgical procedures. Participants were allowed to have solid food, formula milk or cow's milk up to six hours, mother's milk up to four hours and clear fluid up to two hours before surgery.
On reaching the pre-operative room, when the participant was still on mothers lap or on the bed baseline measurements of non-invasive blood pressure (NIBP), pulse oximeter (SpO2) and electrocardiography (ECG) were taken. Fifteen minutes before induction of anesthesia, all participants were premedicated with ketamine, either 4mg/kg intramuscularly into the gluteal region with 26 G needle, or with 0.5mg/kg intravenously if intravenous (IV) cannula was in place.
Devices for ECG, SpO2 and NIBP monitoring were attached to the participant after arrival in the operating room. IV line was then inserted, if not already present. Pre-oxygenation was done with 100% oxygen using an appropriate size face mask. Anesthesia was induced with IV fentanyl (2mcg/kg), and propofol (2-4 mg/kg) until the loss of response to verbal contact or loss of eyelash reflex. Spontaneous ventilation was first assisted and then controlled manually to maintain an end-tidal carbon dioxide partial pressure of 33-40 mmHg. No neuromuscular blocking agent was administered.
Supraorbital pressure or jaw thrust was performed after loss of response to verbal contact, or absence of body movements. In group SOP, supraorbital pressure was applied over the supraorbital notch for five seconds. In group JT, the jaw thrust was applied gently by lifting the angles of the mandible vertically upward for five seconds. An IV bolus dose of propofol (1 mg/kg) was added if there was a motor response to the supraorbital pressure or the jaw thrust and the test was repeated after ten seconds. A second bolus dose of propofol was repeated if positive motor response was still present. A negative physical response to the test was considered as the end point of induction to perform LMA insertion. A classic LMA of appropriate size was inserted immediately. Ease of insertion and mouth opening, development of coughing, swallowing, movement, laryngospasm, or gross purposeful movements during or within one minute of LMA insertion and additional dosage of propofol if required were recorded. The LMA insertion was considered unsuccessful if LMA could not be inserted after administration of second bolus dose of propofol. The number of attempts and the insertion conditions were recorded using a six variable three points scoring system(31)
- Mouth opening: 1 - Full, 2 - Partial (not ideal but permits easy opening of mouth), 3 - Nil
- Ease of LMA insertion 1 - Easy, 2 - Difficult, 3 - Impossible.
- Swallowing: 1 - Nil, 2 - Mild, 3 - Severe
- Coughing: 1 - Nil, 2 - Mild, 3 - Severe
- Laryngospasm: 1 - Nil, 2 - Mild (relieved by positive pressure ventilation), 3 - Severe (desaturation<90%)
- Movement: 1 - Nil, 2 - Mild (Finger) (some movement but did not affect positioning of LMA), 3 - Severe (Arm/leg) (holding of LMA was required and additional dose of induction agent given).
The investigators summed all the five scores to give a LMA insertion condition summed score which ranged from 0 to 12, a lower summed score indicating more favourable LMA insertion conditions.
Table: Laryngeal mask airway insertion score.
Variables 0 1 2
Mouth opening Complete Partial Impossible Ease of insertion Easy Difficult Impossible Swallowing Nil Partial Complete Coughing Nil Partial Complete Laryngospasm Nil Partial Complete Movement Nil Partial Gross
LMA cuff was inflated with air and was connected to Jackson-Rees modification of the Ayre's T-piece. Effective ventilation was determined by observing chest wall and bag movement, auscultation, and capnography.
Blood pressure, heart rate and percentage saturation of oxygen were recorded in the pre-operative room, immediately after LMA insertion, five, ten and fifteen minutes after LMA insertion.
Anesthesia was maintained with isoflurane in oxygen. After the closure of skin incision, removal of LMA was done when the participant was still in deep plane of anesthesia.
- Conditions
- Laryngeal Masks
- Being tested
- Supraorbital pressure, Jaw thrust maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraorbital pressureOther
Supraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow.
Jaw thrust maneuverOther
Jaw thrust is performed by placing the index and middle fingers to physically pull the posterior aspects of the mandible upwards while their thumbs push down on the chin to open the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Supraorbital pressure | Active comparator | Supraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow. Receives: Other: Jaw thrust maneuver |
| Jaw thrust maneuver | Active comparator | Jaw thrust maneuver is performed by placing the index and middle fingers to physically pull the posterior aspects of the mandible upwards while their thumbs push down on the chin to open the mouth. Receives: Other: Supraorbital pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful LMA insertion at first attempt
Measured: Upto 1 minute after LMA insertion
Secondary outcomes (10)
Ease of insertion of LMA
Measured: Upto 1 minute after LMA insertion
Adequacy of mouth opening
Measured: Upto 1 minute after LMA insertion
Incidence of swallowing
Measured: Upto 1 minute after LMA insertion
Incidence of coughing
Measured: Upto 1 minute after LMA insertion
Incidence of laryngospasm
Measured: Upto 1 minute after LMA insertion
Incidence of movement
Measured: Upto 1 minute after LMA insertion
Additional bolus dose of propofol if required
Measured: Upto 1 minute after LMA insertion
LMA insertion score
Measured: Upto 1 minute after LMA insertion
Heart rate
Measured: Upto 5 minute after LMA insertion
Non invasive blood pressure
Measured: Upto 5 minute after LMA insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal MasksStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Asish Subedi, B.P. Koirala Institute of Health Sciences
- Investigators
- Krishna Pokharel, MD, Study director, B.P. Koirala Institute of Health SciencesAsish Subedi, MD, Study director, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618525
- Sponsor's protocol ID
- Acd/10/071/072
- Status last verified
- Dec 2018
- First submitted
- 23 Nov 2015
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Supraorbital Pressure and Jaw Thrust as Indicators for Depth of Anesthesia for Laryngeal Mask Airway Insertion in Children
- ClinicalTrials.gov ID
- NCT02618525
- Acronym / sponsor ID
- Acd/10/071/072
- Conditions
- Laryngeal Masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 1 Dec 2015 (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.
BACKGROUND AND OBJECTIVES
The purpose of this study is to assess whether the loss of motor response to supraorbital pressure can be an alternative to that of jaw thrust to predict optimal condition for laryngeal mask airway (LMA) insertion in children.
METHODOLOGY
Fifty children (ASA I-II), aged 2 to 10 years, scheduled to receive general anesthesia that required LMA insertion were randomized to receive either supraorbital pressure (SOP) (n = 25) or jaw thrust (JT) (n = 25), after the loss of verbal response and body movements with a standard anesthetic. When motor response to the study intervention was absent, the LMA was inserted.
Detailed description
The investigators enrolled fifty consecutive participants (aged one to ten years) with ASA physical status I or II scheduled to receive general anesthesia for various surgical procedures. Participants were allowed to have solid food, formula milk or cow's milk up to six hours, mother's milk up to four hours and clear fluid up to two hours before surgery.
On reaching the pre-operative room, when the participant was still on mothers lap or on the bed baseline measurements of non-invasive blood pressure (NIBP), pulse oximeter (SpO2) and electrocardiography (ECG) were taken. Fifteen minutes before induction of anesthesia, all participants were premedicated with ketamine, either 4mg/kg intramuscularly into the gluteal region with 26 G needle, or with 0.5mg/kg intravenously if intravenous (IV) cannula was in place.
Devices for ECG, SpO2 and NIBP monitoring were attached to the participant after arrival in the operating room. IV line was then inserted, if not already present. Pre-oxygenation was done with 100% oxygen using an appropriate size face mask. Anesthesia was induced with IV fentanyl (2mcg/kg), and propofol (2-4 mg/kg) until the loss of response to verbal contact or loss of eyelash reflex. Spontaneous ventilation was first assisted and then controlled manually to maintain an end-tidal carbon dioxide partial pressure of 33-40 mmHg. No neuromuscular blocking agent was administered.
Supraorbital pressure or jaw thrust was performed after loss of response to verbal contact, or absence of body movements. In group SOP, supraorbital pressure was applied over the supraorbital notch for five seconds. In group JT, the jaw thrust was applied gently by lifting the angles of the mandible vertically upward for five seconds. An IV bolus dose of propofol (1 mg/kg) was added if there was a motor response to the supraorbital pressure or the jaw thrust and the test was repeated after ten seconds. A second bolus dose of propofol was repeated if positive motor response was still present. A negative physical response to the test was considered as the end point of induction to perform LMA insertion. A classic LMA of appropriate size was inserted immediately. Ease of insertion and mouth opening, development of coughing, swallowing, movement, laryngospasm, or gross purposeful movements during or within one minute of LMA insertion and additional dosage of propofol if required were recorded. The LMA insertion was considered unsuccessful if LMA could not be inserted after administration of second bolus dose of propofol. The number of attempts and the insertion conditions were recorded using a six variable three points scoring system(31)
- Mouth opening: 1 - Full, 2 - Partial (not ideal but permits easy opening of mouth), 3 - Nil
- Ease of LMA insertion 1 - Easy, 2 - Difficult, 3 - Impossible.
- Swallowing: 1 - Nil, 2 - Mild, 3 - Severe
- Coughing: 1 - Nil, 2 - Mild, 3 - Severe
- Laryngospasm: 1 - Nil, 2 - Mild (relieved by positive pressure ventilation), 3 - Severe (desaturation<90%)
- Movement: 1 - Nil, 2 - Mild (Finger) (some movement but did not affect positioning of LMA), 3 - Severe (Arm/leg) (holding of LMA was required and additional dose of induction agent given).
The investigators summed all the five scores to give a LMA insertion condition summed score which ranged from 0 to 12, a lower summed score indicating more favourable LMA insertion conditions.
Table: Laryngeal mask airway insertion score.
Variables 0 1 2
Mouth opening Complete Partial Impossible Ease of insertion Easy Difficult Impossible Swallowing Nil Partial Complete Coughing Nil Partial Complete Laryngospasm Nil Partial Complete Movement Nil Partial Gross
LMA cuff was inflated with air and was connected to Jackson-Rees modification of the Ayre's T-piece. Effective ventilation was determined by observing chest wall and bag movement, auscultation, and capnography.
Blood pressure, heart rate and percentage saturation of oxygen were recorded in the pre-operative room, immediately after LMA insertion, five, ten and fifteen minutes after LMA insertion.
Anesthesia was maintained with isoflurane in oxygen. After the closure of skin incision, removal of LMA was done when the participant was still in deep plane of anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraorbital pressure | Active comparator | Other: Jaw thrust maneuverSupraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow. |
| Jaw thrust maneuver | Active comparator | Other: Supraorbital pressureJaw thrust maneuver is performed by placing the index and middle fingers to physically pull the posterior aspects of the mandible upwards while their thumbs push down on the chin to open the mouth. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA physical status 1 and 2
Key exclusion criteria (1 listed)
- Congenital, acute or chronic heart and lung disease, Skull fracture or orbital fracture
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 |
|---|---|---|
| Supraorbital pressureSupraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow. | Other | Jaw thrust maneuver |
| Jaw thrust maneuverJaw thrust is performed by placing the index and middle fingers to physically pull the posterior aspects of the mandible upwards while their thumbs push down on the chin to open the mouth. | Other | Supraorbital pressure |
Primary outcome
Number of successful LMA insertion at first attempt
Time frame: Upto 1 minute after LMA insertion
10 secondary outcomes
Ease of insertion of LMA
Time frame: Upto 1 minute after LMA insertion
Adequacy of mouth opening
Time frame: Upto 1 minute after LMA insertion
Incidence of swallowing
Time frame: Upto 1 minute after LMA insertion
Incidence of coughing
Time frame: Upto 1 minute after LMA insertion
Incidence of laryngospasm
Time frame: Upto 1 minute after LMA insertion
Incidence of movement
Time frame: Upto 1 minute after LMA insertion
Additional bolus dose of propofol if required
Time frame: Upto 1 minute after LMA insertion
LMA insertion score
Time frame: Upto 1 minute after LMA insertion
Heart rate
Time frame: Upto 5 minute after LMA insertion
Non invasive blood pressure
Time frame: Upto 5 minute after LMA insertion
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 26 Dec 2018.
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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.
Krishna Pokharel, MD study director
B.P. Koirala Institute of Health Sciences
Asish Subedi, MD study director
B.P. Koirala Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraorbital pressure and Jaw thrust maneuver in people with Laryngeal Masks, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 1 inclusion and 1 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 26 Dec 2018. 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 Nepal. 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?
Number of successful LMA insertion at first attempt (time frame: Upto 1 minute after LMA insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2018.