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

June 8, 2021 updated by: Sameh Fathy
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Spontaneous Ventilation
Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Procedure: Pressure Support Ventilation
Ventilator will be adjusted to administer pressure at 10 cmH2O.
Other Names:
  • Assisted Ventilation
Device: Laryngeal Mask Airway
Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.
Other Names:
  • Supraglottic Airway Device
Drug: Sevoflurane
Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.
Other Names:
  • Inhalational Anesthesia
ACTIVE_COMPARATOR: Unparalyzed Controlled Ventilation
Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Device: Laryngeal Mask Airway
Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.
Other Names:
  • Supraglottic Airway Device
Drug: Sevoflurane
Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.
Other Names:
  • Inhalational Anesthesia
Procedure: Unparalyzed Pressure Control 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.
Other Names:
  • Positive pressure Ventilation
ACTIVE_COMPARATOR: Paralyzed Controlled Ventilation
Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Device: Laryngeal Mask Airway
Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.
Other Names:
  • Supraglottic Airway Device
Drug: Sevoflurane
Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.
Other Names:
  • Inhalational Anesthesia
Procedure: Paralyzed Pressure Control 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.
Other Names:
  • Positive pressure Ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of eye movements
Time Frame: Up to the end of the surgery
Incidence any upward or downward deviation of the vision axis during surgery will be recorded
Up to the end of the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in intraocular pressure
Time Frame: Up to the end of the surgery
Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer
Up to the end of the surgery
Changes in bispectral index
Time Frame: Up to the end of the surgery
Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery
Up to the end of the surgery
Amount of consumption of sevoflurane
Time Frame: Up to the end of the surgery
Sevoflurane consumption in milliliters will be measured and recorded
Up to the end of the surgery
Changes in dynamic compliance
Time Frame: Up to the end of the surgery
Dynamic compliance (ml /cm H2O) will be recorded after stabilization of ventilation and at the end of surgery
Up to the end of the surgery
Changes in heart rate
Time Frame: Up to the end of the surgery
Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery
Up to the end of the surgery
Changes in mean arterial blood pressure
Time Frame: Up to the end of the surgery
Blood pressure (mmHg) will be recorded at five-minute intervals until the end of the surgery
Up to the end of the surgery
Value of surgeon satisfaction from the procedure
Time Frame: After the end of the surgery
The ophthalmogist will be investigated postoperatively for the quality of surgical field (0-8; 0=None, 8=total satisfaction)
After the end of the surgery
Improvement in postoperative emergence agitation scale
Time Frame: Up to 30 minutes after surgery
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)
Up to 30 minutes after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sameh Fathy

Investigators

  • Study Director: Sameh M El-Sherbiny, MD, Mansoura faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2020

Primary Completion (ACTUAL)

January 10, 2021

Study Completion (ACTUAL)

February 9, 2021

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (ACTUAL)

January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ventilation with LMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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