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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03361657
Collaborator
(none)
29
1
11.4
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    29 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
    Actual Study Start Date :
    Dec 20, 2017
    Actual Primary Completion Date :
    Dec 1, 2018
    Actual Study Completion Date :
    Dec 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. PaCO2-ETCO2 Difference [Intraoperative]

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

    2. Heart rate [Intraoperative]

      The heart rate will be continuously monitored, intraoperatively

    3. The noninvasive systolic and diastolic arterial blood pressure [intraoperative]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university Pediatric hospital Assiut Assiut Governorate Egypt 715715

    Sponsors and Collaborators

    • Assiut University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Saad Abdel-Ghaffar, principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03361657
    Other Study ID Numbers:
    • 17300081
    First Posted:
    Dec 5, 2017
    Last Update Posted:
    Apr 8, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 8, 2020