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

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ClinicalTrials.gov Identifier: NCT03361657
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, 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.

Condition or disease Intervention/treatment Phase
Intraoperative Ventilation Device: IAP 8mmHg Device: IAP 10mmHg Device: IAP 12 mmHg Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The surgical team performed a laparoscopy using a Hasson technique for the umbilical corkscrew port insertion (a three-port approach), 5-mm instruments. Insufflation pressures were set at 8, or 10 or 12 mmHg according to group assignment and continuously measured using the GS 1002 402 Insufflator (ConMed Linvatec, Largo, FL, USA).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Randomization will be done according to a computer-generated randomized number table. Data collection will be done by well-trained investigators not involved in the study. Patients' guardians and all study personnel will be blinded to group assignment.
Primary Purpose: Treatment
Official Title: Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group I
IAP 8mmHg 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 8mmHg
Device: IAP 8mmHg
The surgical team will perform a laparoscopy using a Hasson technique for the umbilical corkscrew port insertion (a three-port approach), 5-mm instruments. Insufflation pressures will be set at 8 mmHg and continuously measured using the GS 1002 402 Insufflator (ConMed Linvatec, Largo, FL, USA).

Active Comparator: Group II
IAP 10mmHg 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 mmHg
Device: IAP 10mmHg
The surgical team will perform a laparoscopy using a Hasson technique for the umbilical corkscrew port insertion (a three-port approach), 5-mm instruments. Insufflation pressures will be set at 10 mmHg and continuously measured using the GS 1002 402 Insufflator (ConMed Linvatec, Largo, FL, USA).

Active Comparator: Group III
IAP 12mmHg 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 12 mmHg
Device: IAP 12 mmHg
The surgical team will perform a laparoscopy using a Hasson technique for the umbilical corkscrew port insertion (a three-port approach), 5-mm instruments. Insufflation pressures will be set at 12 mmHg and continuously measured using the GS 1002 402 Insufflator (ConMed Linvatec, Largo, FL, USA).




Primary Outcome Measures :
  1. Arterial to end-tidal carbon dioxide difference [PaCO2-PetCO2] [ 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 Outcome Measures :
  1. Blood pressure [ Time Frame: Intraoperative ]
    The noninvasive blood pressure will be measured every 5min., intraoperatively.

  2. Heart rate [ Time Frame: Intraoperative ]
    The heart rate will be continuously monitored, intraoperatively



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361657


Contacts
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Contact: Hala S Abdelghaffar, MD 1003812011 ext +2088 hallasaad@yahoo.com
Contact: Sara G Labib, MBBCH drsarah1992@yahoo.com

Locations
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Egypt
Assiut university Pediatric hospital Recruiting
Assiut, Assiut Governorate, Egypt, 715715
Contact: Hala S Abdel-Ghaffar, MD    +2 01003812011    hallasaad@yahoo.com   
Contact: sara G Labib, MBBCH       drsarah1992@yahoo.com   
Sub-Investigator: Mohamed A Osman, MD         
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Hala Abdelghaffar, MD professor in Anesthesia department, faculty of medicine, Assiut university, Assiut, Egypt

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Responsible Party: Hala Saad Abdel-Ghaffar, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03361657     History of Changes
Other Study ID Numbers: 17300081
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No