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VentilationNCT04241653

Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery

A study testing Pressure Support Ventilation, Laryngeal Mask Airway and Sevoflurane in people with Ventilation and Laryngeal Mask Airway, run by Sameh Fathy at 1 site in Egypt.

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

This study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post operative recovery. Read more about this study

Who is it for?
Ages 1 year to 5 years
What is being tested?
Pressure Support Ventilation, Laryngeal Mask Airway and Sevoflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteEgypt
Study dates
20 Jan 2020to 9 Feb 2021
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 1 year to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • American Society of Anesthesiology (ASA) I and II patients.
  • Scheduled for elective cataract surgery.

Who cannot join

  • Parental refusal of consent.
  • Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology.
  • Hyperactive airway disease or respiratory diseases.
  • Children with developmental delays, mental or neurological disorders.
  • Bleeding or coagulation diathesis.
  • History of known sensitivity to the used anesthetics.
  • Previous surgery in the same eye.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Department of Anesthesia, Mansoura University Hospitals

    Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

This study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post operative recovery. It is hypothesized that controlled ventilation without muscle relaxation will be advantageous to other modes in providing adequate surgical satisfaction with considerable depth of anesthesia and better recovery profile.

Read the detailed description

Anesthetic management in pediatric cataract surgery constitutes a special challenge. Any eye movements can lead to an unsatisfactory surgical field and increase the risk of ophthalmological complications. Achieving adequate ventilation of children is considered another challenge due to huge variability in size and lung maturity. Spontaneous breathing is a popular mode of ventilation with several beneficial effects. Controlled ventilation without muscle relaxation using laryngeal mask airway is attractive option because the side effects of muscle relaxants are avoided. Therefore, this study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post-operative recovery. This prospective, randomized, comparative clinical study will include 150 children who will be scheduled for elective cataract surgery under general anesthesia in Mansoura ophthalmology center over one year. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality.The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to three equal groups according to computer-generated table of random numbers using the permuted block randomization method. In the first group, spontaneous ventilation will be maintained with pressure support; while in the two other groups, mechanical ventilation will be applied with pressure controlled modes. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.

Being tested
Pressure Support Ventilation, Unparalyzed Pressure Control Ventilation, Paralyzed Pressure Control Ventilation, Laryngeal Mask Airway, Sevoflurane
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pressure Support VentilationProcedure or surgery

    Also called Assisted Ventilation

    Ventilator will be adjusted to administer pressure at 10 cmH2O.

  • Unparalyzed Pressure Control VentilationProcedure or surgery

    Also called Positive pressure Ventilation

    Pressure controlled ventilation mode will be applied to obtain a volume of 8 ml/kg up to 20 cmH2O. The set respiratory rate will be 15 breaths/min then it is adjusted to achieve the end tidal CO2 levels between 35 and 40 mmHg as measured by capnography.

  • Paralyzed Pressure Control VentilationProcedure or surgery

    Also called Positive pressure Ventilation

    Pressure controlled ventilation mode will be applied to obtain a volume of 8 ml/kg up to 20 cmH2O. The set respiratory rate will be 15 breaths/min then it is adjusted to achieve the end tidal CO2 levels between 35 and 40 mmHg as measured by capnography. Also, neuromuscular blockade will be achieved.

  • Laryngeal Mask AirwayDevice

    Also called Supraglottic Airway Device

    Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.

  • SevofluraneDrug

    Also called Inhalational Anesthesia

    Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.

Study groups in NCT04241653
Study groupRoleWhat they receive
Spontaneous VentilationActive comparatorPatients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Receives: Procedure: Pressure Support Ventilation; Device: Laryngeal Mask Airway; Drug: Sevoflurane
Unparalyzed Controlled VentilationActive comparatorPatients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Receives: Procedure: Unparalyzed Pressure Control Ventilation; Device: Laryngeal Mask Airway; Drug: Sevoflurane
Paralyzed Controlled VentilationActive comparatorPatients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Receives: Procedure: Paralyzed Pressure Control Ventilation; Device: Laryngeal Mask Airway; Drug: Sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of eye movements

    Incidence any upward or downward deviation of the vision axis during surgery will be recorded

    Measured: Up to the end of the surgery

Secondary outcomes (8)

  1. Changes in intraocular pressure

    Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer

    Measured: Up to the end of the surgery

  2. Changes in bispectral index

    Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery

    Measured: Up to the end of the surgery

  3. Amount of consumption of sevoflurane

    Sevoflurane consumption in milliliters will be measured and recorded

    Measured: Up to the end of the surgery

  4. Changes in dynamic compliance

    Dynamic compliance (ml /cm H2O) will be recorded after stabilization of ventilation and at the end of surgery

    Measured: Up to the end of the surgery

  5. Changes in heart rate

    Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery

    Measured: Up to the end of the surgery

  6. Changes in mean arterial blood pressure

    Blood pressure (mmHg) will be recorded at five-minute intervals until the end of the surgery

    Measured: Up to the end of the surgery

  7. Value of surgeon satisfaction from the procedure

    The ophthalmogist will be investigated postoperatively for the quality of surgical field (0-8; 0=None, 8=total satisfaction)

    Measured: After the end of the surgery

  8. Improvement in postoperative emergence agitation scale

    Agitation will be assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes. (1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)

    Measured: Up to 30 minutes after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start20 Jan 2020
  3. Primary completion10 Jan 2021
  4. Study completion9 Feb 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04241653
Sponsor's protocol ID
Ventilation with LMA
Status last verified
Jun 2021
First submitted
23 Jan 2020
Last updated
10 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dias R, Dave N, Agrawal B, Baghele A. Correlation between bispectral index, end-tidal anaesthetic gas concentration and difference in inspired-end-tidal oxygen concentration as measures of anaesthetic depth in paediatric patients posted for short surgical procedures. Indian J Anaesth. 2019 Apr;63(4):277-283. doi: 10.4103/ija.IJA_653_18.

    PubMed 31000891

  • Fudickar A, Gruenewald M, Fudickar B, Hill M, Wallenfang M, Hullemann J, Voss D, Caliebe A, Roider JB, Steinfath M, Treumer F. Immobilization during anesthesia for vitrectomy using a laryngeal mask without neuromuscular blockade versus endotracheal intubation and neuromuscular blockade. Minerva Anestesiol. 2018 Jul;84(7):820-828. doi: 10.23736/S0375-9393.17.12282-0. Epub 2017 Oct 12.

    PubMed 29027777

  • Ghabach MB, El Hajj EM, El Dib RD, Rkaiby JM, Matta MS, Helou MR. Ventilation of Nonparalyzed Patients Under Anesthesia with Laryngeal Mask Airway, Comparison of Three Modes of Ventilation: Volume Controlled Ventilation, Pressure Controlled Ventilation, and Pressure Controlled Ventilation-volume Guarantee. Anesth Essays Res. 2017 Jan-Mar;11(1):197-200. doi: 10.4103/0259-1162.200238.

    PubMed 28298784

  • Lewis SR, Pritchard MW, Fawcett LJ, Punjasawadwong Y. Bispectral index for improving intraoperative awareness and early postoperative recovery in adults. Cochrane Database Syst Rev. 2019 Sep 26;9(9):CD003843. doi: 10.1002/14651858.CD003843.pub4.

    PubMed 31557307

  • Waldschmidt B, Gordon N. Anesthesia for pediatric ophthalmologic surgery. J AAPOS. 2019 Jun;23(3):127-131. doi: 10.1016/j.jaapos.2018.10.017. Epub 2019 Apr 14.

    PubMed 30995517

  • Singh PM, Trikha A, Sinha R, Borle A. Measurement of consumption of sevoflurane for short pediatric anesthetic procedures: Comparison between Dion's method and Dragger algorithm. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):516-20. doi: 10.4103/0970-9185.119160.

    PubMed 24249990

  • Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth. 2017 Mar 1;118(3):335-343. doi: 10.1093/bja/aew477.

    PubMed 28203739

Questions about this trial

What is this clinical trial studying?

A study testing Pressure Support Ventilation, Laryngeal Mask Airway and Sevoflurane in people with Ventilation and Laryngeal Mask Airway, run by Sameh Fathy at 1 site in Egypt.

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 2 inclusion and 7 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 10 Jun 2021. 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 Egypt. 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?

Incidence of eye movements (time frame: Up to the end of the surgery). 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 NCT04241653, which also lists 7 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 10 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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