Intraoperative VentilationPaCO2-EtCO2NCT03361657
Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
An observational study of Intraoperative Ventilation, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Intraoperative Ventilation
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university Pediatric hospital
Asyut, Assiut Governorate, 715715
About this study
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.
Read the 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.
- Conditions
- Intraoperative Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the Arterial to end-tidal carbon dioxide
The arterial CO2 will be analysed from the blood gas and the endtidal carbon dioxide will be recorded from the capnography tracing.
Measured: Intraoperative
Secondary outcomes (3)
PaCO2-ETCO2 Difference
The arterial CO2 will be analysed from the blood gas and the endtidal carbon dioxide will be recorded from capnography.
Measured: Intraoperative
Heart rate
The heart rate will be continuously monitored, intraoperatively
Measured: Intraoperative
The noninvasive systolic and diastolic arterial blood pressure
The non invasive systolic and diastolic arterial blood pressure will be recorded at fixed intervals
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start20 Dec 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative VentilationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala Abdelghaffar, MD, Principal investigator, professor in Anesthesia department, faculty of medicine, Assiut university, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361657
- Sponsor's protocol ID
- 17300081
- Acronym
- PaCO2-EtCO2
- Status last verified
- Apr 2020
- First submitted
- 29 Nov 2017
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34411630
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
- ClinicalTrials.gov ID
- NCT03361657
- Acronym / sponsor ID
- PaCO2-EtCO2 / 17300081
- Conditions
- Intraoperative Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- Children with the following inclusion criteria;
- Weight: 10-30 kg.
- Age: 1-6 years.
- Sex: both males and females.
- ASA physical status: I, II.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
PaCO2-ETCO2 Difference
Time frame: Intraoperative
Heart rate
Time frame: Intraoperative
The noninvasive systolic and diastolic arterial blood pressure
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Derived from this study: PubMed 34411630Abdel-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Abdelghaffar, MD principal investigator
professor in Anesthesia department, faculty of medicine, Assiut university, Assiut, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Ventilation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the Arterial to end-tidal carbon dioxide (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03361657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.