Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries (PaCO2-EtCO2)

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Ventilation

Detailed Description

Capnography provides a non-invasive estimate of arterial CO2 levels and allows clinicians to modify mechanical ventilation settings in order to maintain normocapnia. Normally, a positive gap between arterial CO2 and ETCO2 of approximately 0.5 kPa is assumed in a healthy patient and ventilation settings are adjusted accordingly. However, the correlation between PaCO2 and PetCO2 during laparoscopic surgery is inconsistent mainly due to inter- and intra-individual variability. Discrepancies between arterial carbon dioxide and End-tidal carbon dioxide measures have been demonstrated in ventilated children with cyanotic congenital heart disease , infants with respiratory failure and during visceral and urological laparoscopic surgery. Moreover, as the increase in PaCO2 is directly proportional to the level of intra-abdominal pressure (IAP) used, variations in the arterial to end-tidal carbon dioxide difference can be also expected with different levels of IAP used.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Egypt
  • Assiut Governorate
    • Assiut, Assiut Governorate, Egypt, 715715
      • Assiut University Pediatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Children with the following inclusion criteria;
• 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaCO2-ETCO2 Difference	The arterial CO2 will be analysed from the blood gas and the endtidal carbon dioxide will be recorded from capnography.	Intraoperative
Heart rate	The heart rate will be continuously monitored, intraoperatively	Intraoperative
The noninvasive systolic and diastolic arterial blood pressure	The non invasive systolic and diastolic arterial blood pressure will be recorded at fixed intervals	intraoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala Abdelghaffar, MD, professor in Anesthesia department, faculty of medicine, Assiut university, Assiut, Egypt

Publications and helpful links

General Publications

• 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. 2021 Aug 16:S0104-0014(21)00326-2. doi: 10.1016/j.bjane.2021.07.036. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2017
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (ACTUAL): December 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17300081

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