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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Nepal1 site
  • B. P. Koirala Institute Of Health Sciences

    Dharān

Other trials in Nepal

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 groups in NCT02618525
Study groupRoleWhat they receive
Supraorbital pressureActive comparatorSupraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow.
Receives: Other: Jaw thrust maneuver
Jaw thrust maneuverActive comparatorJaw 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.

  1. Number of successful LMA insertion at first attempt

    Measured: Upto 1 minute after LMA insertion

Secondary outcomes (10)
  1. Ease of insertion of LMA

    Measured: Upto 1 minute after LMA insertion

  2. Adequacy of mouth opening

    Measured: Upto 1 minute after LMA insertion

  3. Incidence of swallowing

    Measured: Upto 1 minute after LMA insertion

  4. Incidence of coughing

    Measured: Upto 1 minute after LMA insertion

  5. Incidence of laryngospasm

    Measured: Upto 1 minute after LMA insertion

  6. Incidence of movement

    Measured: Upto 1 minute after LMA insertion

  7. Additional bolus dose of propofol if required

    Measured: Upto 1 minute after LMA insertion

  8. LMA insertion score

    Measured: Upto 1 minute after LMA insertion

  9. Heart rate

    Measured: Upto 5 minute after LMA insertion

  10. 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.

  1. First posted1 Dec 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

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)
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

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.

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