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OpenTrials
Completed

NCT Number: NCT03361657

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

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.

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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation between the Arterial to end-tidal carbon dioxide

    Time frame: Intraoperative

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

Secondary outcomes

  1. PaCO2-ETCO2 Difference

    Time frame: Intraoperative

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

  2. Heart rate

    Time frame: Intraoperative

    The heart rate will be continuously monitored, intraoperatively

  3. The noninvasive systolic and diastolic arterial blood pressure

    Time frame: intraoperative

    The non invasive systolic and diastolic arterial blood pressure will be recorded at fixed intervals

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: PaCO2-EtCO2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2017
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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