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Trial record 46 of 1688 for:    CARBON DIOXIDE AND dioxide

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

Tracking Information
First Submitted Date  ICMJE November 29, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date January 11, 2018
Actual Study Start Date  ICMJE November 20, 2017
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03361657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • Blood pressure [ Time Frame: Intraoperative ]
    The noninvasive blood pressure will be measured every 5min., intraoperatively.
  • Heart rate [ Time Frame: Intraoperative ]
    The heart rate will be continuously monitored, intraoperatively
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
Official Title  ICMJE Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Intraoperative Ventilation
Intervention  ICMJE
  • 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).
  • 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).
  • 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).
Study Arms  ICMJE
  • 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
    Intervention: Device: IAP 8mmHg
  • 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
    Intervention: Device: IAP 10mmHg
  • 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
    Intervention: Device: IAP 12 mmHg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hala S Abdelghaffar, MD 1003812011 ext +2088 hallasaad@yahoo.com
Contact: Sara G Labib, MBBCH drsarah1992@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03361657
Other Study ID Numbers  ICMJE 17300081
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hala Saad Abdel-Ghaffar, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hala Abdelghaffar, MD professor in Anesthesia department, faculty of medicine, Assiut university, Assiut, Egypt
PRS Account Assiut University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP