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

Completed

• Conditions: Intraoperative Ventilation

• Registration Number: NCT03361657
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Study Start: 2017-12-20
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between the Arterial to end-tidal carbon dioxide	Intraoperative	The arterial CO2 will be analysed from the blood gas and the endtidal carbon dioxide will be recorded from the capnography tracing.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assiut university Pediatric hospital; 🇪🇬 Assiut, Assiut Governorate, Egypt