Clinical trial NCT03361657: Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
Official title: Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraoperative Ventilation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 29
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between the Arterial to end-tidal carbon dioxide
timeFrame: Intraoperative
Secondary outcomes:
measure: PaCO2-ETCO2 Difference
timeFrame: Intraoperative
measure: Heart rate
timeFrame: Intraoperative
measure: The noninvasive systolic and diastolic arterial blood pressure
timeFrame: intraoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university Pediatric hospital
state: Assiut Governorate
Study officials:
affiliation: professor in Anesthesia department, faculty of medicine, Assiut university, Assiut, Egypt
name: Hala Abdelghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.