Volume Versus Pressure Ventilation on Lung Atelectasis

NCT06076395 | Unknown DMC

• 1 other identifier: MS-96-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with LMA (laryngeal mask airway) under volume versus pressure controlled modes of ventilation.

Conditions

Cardiac Congenital Defects

Keywords

pediatric cardiac catheterization; lung ultrasound score; lung atelectasis; LMA

Outcome Measures

Primary Outcomes (1)

• Post operative incidence of Lung atelectasis immediate post-removal of LMA.

  calculate lung score using lung ultrasound

  immediated post removal of LMA

Secondary Outcomes (1)

• Correlation between lung score and PaO2 /FiO2 ratio

  From the preoperative period (T0) to 30 minutes post-extubation

Study Arms (2)

Group A pressure control ventilation

EXPERIMENTAL

Inspiratory pressure was adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O and FiO2 at 0.5 providing that the maximum airway pressure was limited to 25 cmH2O.

Device: LMA (Laryngeal Mask Airway)

Group B volume control ventilation

EXPERIMENTAL

VT adjacent to 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and PEEP at 4 cm H2O and FiO2 at 0.5.

Device: LMA (Laryngeal Mask Airway)

Interventions

LMA (Laryngeal Mask Airway) DEVICE

Pressure controlled versus Volume controlled ventilation using LMA

Also known as: Lung Ultrasound

Group A pressure control ventilation; Group B volume control ventilation

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients undergoing cardiac catheterization procedures. Age from 2 years to 6 years of both sexes.

You may not qualify if:

• Lung score at different times.
• Age \<2 years and \>6 years.
• Preoperative mechanical ventilation.
• Heart failure (any inotropic support infusion).
• Patients with any lung diseases( acute respiratory disease, pulmonary or lung
• diseases).
• Lung consolidation score ≥ 2 before insertion of LMA.
• Any contraindication for LMA insertion (risk for aspiration, and/or airway
• obstruction below the larynx.)
• Procedures exceeding 120 mins duration.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Dalia Saad

Cairo, Egypt

Location

Related Publications (6)

• Hedenstierna G. Airway closure, atelectasis and gas exchange during anaesthesia. Minerva Anestesiol. 2002 May;68(5):332-6.

  PMID: 12029240 BACKGROUND

• Stefanik E, Drewnowska O, Lisowska B, Turek B. Causes, Effects and Methods of Monitoring Gas Exchange Disturbances during Equine General Anaesthesia. Animals (Basel). 2021 Jul 9;11(7):2049. doi: 10.3390/ani11072049.

  PMID: 34359177 BACKGROUND

• Chiumello D, Mongodi S, Algieri I, Vergani GL, Orlando A, Via G, Crimella F, Cressoni M, Mojoli F. Assessment of Lung Aeration and Recruitment by CT Scan and Ultrasound in Acute Respiratory Distress Syndrome Patients. Crit Care Med. 2018 Nov;46(11):1761-1768. doi: 10.1097/CCM.0000000000003340.

  PMID: 30048331 BACKGROUND

• Rodriguez-Fanjul J, Corsini I, Orti CS, Bobillo-Perez S, Raimondi F. Lung ultrasound to evaluate lung recruitment in neonates with respiratory distress (RELUS study). Pediatr Pulmonol. 2022 Oct;57(10):2502-2510. doi: 10.1002/ppul.26066. Epub 2022 Jul 12.

  PMID: 35792663 BACKGROUND

• Li X, Liu B, Wang Y, Xiong W, Zhang Y, Bao D, Liang Y, Li L, Liu G, Jin X. The effects of laryngeal mask airway versus endotracheal tube on atelectasis in patients undergoing general anesthesia assessed by lung ultrasound: A protocol for a prospective, randomized controlled trial. PLoS One. 2022 Sep 9;17(9):e0273410. doi: 10.1371/journal.pone.0273410. eCollection 2022.

  PMID: 36084154 BACKGROUND

• Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.

  PMID: 24662376 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Amel Hanfy Abo El- Ela

  Kasr El Aini Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly allocated by a computer-generated list (www.randomization.com) into one of the study groups in the day of the study . The randomization sequence will be concealed in sealed envelopes and will be opened by an independent nurse. The data collector and data analysis will be blind to group assignments.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: For group A pressure control ventilation will be adjusted as follows: Inspiratory pressure will be adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H 2 O and FiO2 at 0.5 providing that the maximum airway pressure will be limited to 25 cmH2O. For group B volume control ventilation will be adjusted as follows: tidal volume (VT) adjacent to 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and positive end expiratory pressure (PEEP)at 4 cmH2O and FiO2 at 0.5.

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: January 12, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)