Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries

NCT03361657 | Completed DMC

• 1 other identifier: 17300081
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Studying the arterial to end-tidal carbon dioxide difference in children undergoing laparoscopic surgeries under different intra-abdominal pressures is of extreme importance. This is because both hyper and hypocarbia are detrimental in this vulnerable age group.

Conditions

Intraoperative Ventilation

Outcome Measures

Primary Outcomes (1)

• Correlation between the Arterial to end-tidal carbon dioxide

  The arterial CO2 will be analysed from the blood gas and the endtidal carbon dioxide will be recorded from the capnography tracing.

  Intraoperative

Secondary Outcomes (3)

• PaCO2-ETCO2 Difference

  Intraoperative

• Heart rate

  Intraoperative

• The noninvasive systolic and diastolic arterial blood pressure

  intraoperative

Study Arms (1)

One sample

Laparoscopic surgeries will be performed according to the standard surgical and anesthesia protocols. Pneumo-peritoneum will be achieved using non-heated non-humidified CO2 with the intra-abdominal pressure (IAP) maintained at 10-12mmHg

Eligibility Criteria

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

Study Population

Children scheduled for laparoscopic surgery of Weight: 10-30 kg, Age: 1-6 years, both males and females,ASA physical status: I, II.

You may qualify if:

• Weight: 10-30 kg.
• Age: 1-6 years.
• Sex: both males and females.
• ASA physical status: I, II.
• Operation: elective laparoscopic surgeries that last more than 45 min.

You may not qualify if:

• Patients will be excluded if they have;
• Patients with any perioperative cardiovascular or respiratory event occurred which made the study intervention clinically unacceptable,
• Patients with unsatisfactory preoperative peripheral arterial oxygen saturation,
• Patients with unsatisfactory preoperative hemoglobin level, neurological or psychiatric disease,
• Children with a BMI \>95th percentile for age.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

Location

Related Publications (1)

• Abdel-Ghaffar HS, Bakr MA, Osman MA, Hanna SGL, Ali WN. End-tidal carbon dioxide measurements as a surrogate to arterial carbon dioxide during pediatric laparoscopic surgeries: a prospective observational cohort study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744261. doi: 10.1016/j.bjane.2021.07.036. Epub 2021 Aug 16.

  PMID: 34411630 DERIVED

Study Officials

• Hala Abdelghaffar, MD

  professor in Anesthesia department, faculty of medicine, Assiut university, Assiut, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: December 20, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)