Effect of Sustained Inflations on Lung Atelectasis During Pediatric Laparoscopic Surgery

NCT05647434 | Unknown

• 1 other identifier: MD-240-2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to assess the beneficial effect of sustained inflations as a recruitment manoeuvre, using LUS examinations, on the degree of lung atelectasis that occurs in pediatric patients undergoing laparoscopic surgery. Objectives

• To assess the effect of general anaesthesia and capnoperitoneum on lung atelectasis in the paediatric patients by using LUS examination
• To assess the effect of sustained inflations as a recruitment manoeuvre in decreasing lung atelectasis caused by general anaesthesia and capnoperitoneum by using LUS examination Hypothesis Our main hypothesis is that the use of repeated Sustained Inflation as a recruitment manoeuvre in pediatric patients undergoing laparoscopic surgery will result in decreased atelectasis compared to conventional ventilation.

Conditions

Ventilator Lung

Outcome Measures

Primary Outcomes (1)

• The lung aeration score by ultrasound

  Four Lung ultrasound patterns were defined according to the degree of B lines: (0) fewer than three isolated B lines; (1) multiple well defined B lines; (2) multiple coalescent B lines and (3) white lung. The sum of the points obtained in all the 12 lung areas will constitute the lung aeration score, ranging from 0-36 for the whole thorax. This score is inversely proportional to the degree of lung aeration and directly proportional to the degree of lung atelectasis.

  from start of surgery till half an hour postoperative

Secondary Outcomes (1)

• Incidence of hemodynamic instability or oxygen desaturation

  from start of surgery till half an hour postoperative

Study Arms (2)

group C

NO INTERVENTION

conventional ventilation

group SI

ACTIVE COMPARATOR

Sustained inflations done after ultrasound during capnoperitoneum every 20 min.

Procedure: sustained inflations

Interventions

sustained inflations PROCEDURE

Sustained inflation will be applied at a pressure of 30 cmH2O and will be held for a period of 30 secs. After each SI the standard ventilatory settings will be resumed with a PEEP setting of 8 cmH2O to prevent lung derecruitment. Lung recruitment will be stopped immediately if mean arterial pressure and/or heart rate change by at least 25% from baseline values.

group SI

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed Informed Parental Consent
• Scheduled for undergoing abdominal laparoscopic surgery
• American Society of Anaesthesiologists (ASA) physical status classification Ⅰ-Ⅱ

You may not qualify if:

• Emergency and thoracic procedures
• Significant pre-existing pulmonary, cardiac or chest wall diseases
• Abdominal distension
• Acute airway infection
• Previous thoracic procedure

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy

Cairo, 11562, Egypt

RECRUITING

Related Publications (5)

• Forgiarini Junior LA, Esquinas AM. [Atelectasis in postoperative bariatric surgery: how many understand them?]. Braz J Anesthesiol. 2018 Jan-Feb;68(1):109-110. doi: 10.1016/j.bjan.2017.01.004. Epub 2017 May 24. No abstract available.

  PMID: 28551061 BACKGROUND

• Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.

  PMID: 27829093 BACKGROUND

• Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

  PMID: 28186222 BACKGROUND

• Malbrain ML, De Laet I, De Waele JJ, Sugrue M, Schachtrupp A, Duchesne J, Van Ramshorst G, De Keulenaer B, Kirkpatrick AW, Ahmadi-Noorbakhsh S, Mulier J, Pelosi P, Ivatury R, Pracca F, David M, Roberts DJ. The role of abdominal compliance, the neglected parameter in critically ill patients - a consensus review of 16. Part 2: measurement techniques and management recommendations. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):406-32. doi: 10.5603/AIT.2014.0063.

  PMID: 25432559 BACKGROUND

• Yang D, Grant MC, Stone A, Wu CL, Wick EC. A Meta-analysis of Intraoperative Ventilation Strategies to Prevent Pulmonary Complications: Is Low Tidal Volume Alone Sufficient to Protect Healthy Lungs? Ann Surg. 2016 May;263(5):881-7. doi: 10.1097/SLA.0000000000001443.

  PMID: 26720429 BACKGROUND

Central Study Contacts

Ahmed H. Sayed, M.D

CONTACT

+201068112464; drahmedhusseinanesth87@gmail.com

karim k. fahim, M.D

CONTACT

+201222457666

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: lung ultrasound will be done by same doctor in both groups who is trained in lung ultrasound he will enter operating room only during ultrasound examination. not to know sustained inflations done in which cases
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia , surgical ICU and pin managment

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 12, 2022
• Study Start: December 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)