Esophageal NeoplasmsNCT02330536
Cardiopulmonary Effects of Intrathoracic Pressure Overshoot During Carbon Dioxide Insufflation in Thoracoscopic Surgery
A study testing Insufflation of carbon dioxide (CO2) in people with Esophageal Neoplasms, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Trial summary
Video-assisted thoracoscopic surgery (VATS) has become a standard technique for addressing all types of thoracic pathology. Insufflation of carbon dioxide (CO2) into the operated chest cavity could increase lung collapse and improve surgical field view. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Insufflation of carbon dioxide (CO2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jul 2020
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status Ⅰ,Ⅱ
- Patients with esophageal carcinoma
- Elective video-assisted thoracic surgery
Who cannot join
- Allergic to drugs used in the study
- Refusal of VAST
- Arrhythmia or treated with antiarrhythmic drug
- Surgery type were converted to thoracotomy,
- Massive intraoperative blood loss (> 400ml)
About this study
Video-assisted thoracoscopic surgery (VATS) has become a standard technique for addressing all types of thoracic pathology. Insufflation of carbon dioxide (CO2) into the operated chest cavity could increase lung collapse and improve surgical field view. The actual thoracic pressure values may not be identical with the presetting on the insufflator display. This overshoot pressure during VATS may compromise cardiac and pulmonary function. The purpose of this study is to evaluate the effects of intrathoracic pressure overshoot during two-lung ventilation on the hemodynamic and respiratory function and clarify the relative safety of two different techniques of insufflation.
- Conditions
- Esophageal Neoplasms
- Being tested
- Insufflation of carbon dioxide (CO2)
- Keywords
- Circulatory and Respiratory Physiological Phenomena, Thoracoscopy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insufflation of carbon dioxide (CO2)Device
After patients were positioned, CO2 was insufflated into right pleural cavity at eight or twenty L/min. during video-assisted thoracoscopic surgery, thoracic pressure, hemodynamic and respiratory parameters were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Flowrate A | Experimental | insufflation of carbon dioxide at 8L/min, 8mmHg Receives: Device: Insufflation of carbon dioxide (CO2) |
| Flowrate B | Experimental | insufflation of carbon dioxide at 20 L/min, 8mmHg Receives: Device: Insufflation of carbon dioxide (CO2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
thoracic pressure overshoot
Time and value of thoracic pressure overshoot during CO2 insufflation
Measured: one hour during CO2 insufflation
Hemodynamic change
Hemodynamic changes during each overshoot including Systolic Blood Pressure, Central Venous Pressure and Heart Rate
Measured: one hour during CO2 insufflation
Respiratory change
Respiratory changes during each overshoot including Peak Inspiratory Pressure, Pressure flat, Arterial Oxygen Saturation and End-tidal Carbon dioxide
Measured: one hour during CO2 insufflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingxiang Mao, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330536
- Sponsor's protocol ID
- QMao
- Status last verified
- Feb 2021
- First submitted
- 24 Dec 2014
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Claus CM, Cury Filho AM, Boscardim PC, Andriguetto PC, Loureiro MP, Bonin EA. Thoracoscopic enucleation of esophageal leiomyoma in prone position and single lumen endotracheal intubation. Surg Endosc. 2013 Sep;27(9):3364-9. doi: 10.1007/s00464-013-2918-3. Epub 2013 Apr 3.
PubMed 23549763El-Dawlatly AA, Al-Dohayan A, Abdel-Meguid ME, Turkistani A, Alotaiby WM, Abdelaziz EM. Variations in dynamic lung compliance during endoscopic thoracic sympathectomy with CO2 insufflation. Clin Auton Res. 2003 Dec;13 Suppl 1:I94-7. doi: 10.1007/s10286-003-1120-4.
PubMed 14673684Brock H, Rieger R, Gabriel C, Polz W, Moosbauer W, Necek S. Haemodynamic changes during thoracoscopic surgery the effects of one-lung ventilation compared with carbon dioxide insufflation. Anaesthesia. 2000 Jan;55(1):10-6. doi: 10.1046/j.1365-2044.2000.01123.x.
PubMed 10594427Ren Y, Zhu X, Yan H, Chen L, Mao Q. Cardiorespiratory impact of intrathoracic pressure overshoot during artificial carbon dioxide pneumothorax: a randomized controlled study. BMC Anesthesiol. 2022 Mar 23;22(1):76. doi: 10.1186/s12871-022-01621-9.
PubMed 35321653
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Effects of Intrathoracic Pressure Overshoot During Carbon Dioxide Insufflation in Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT02330536
- Acronym / sponsor ID
- QMao
- Conditions
- Esophageal Neoplasms
- Keywords
- Circulatory and Respiratory Physiological Phenomena, Thoracoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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.
Video-assisted thoracoscopic surgery (VATS) has become a standard technique for addressing all types of thoracic pathology. Insufflation of carbon dioxide (CO2) into the operated chest cavity could increase lung collapse and improve surgical field view. The actual thoracic pressure values may not be identical with the presetting on the insufflator display. This overshoot pressure during VATS may compromise cardiac and pulmonary function. The purpose of this study is to evaluate the effects of intrathoracic pressure overshoot during two-lung ventilation on the hemodynamic and respiratory function and clarify the relative safety of two different techniques of insufflation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flowrate A | Experimental | Device: Insufflation of carbon dioxide (CO2)insufflation of carbon dioxide at 8L/min, 8mmHg |
| Flowrate B | Experimental | Device: Insufflation of carbon dioxide (CO2)insufflation of carbon dioxide at 20 L/min, 8mmHg |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) Physical Status Ⅰ,Ⅱ
- Patients with esophageal carcinoma
- Elective video-assisted thoracic surgery
Key exclusion criteria (5 listed)
- Allergic to drugs used in the study
- Refusal of VAST
- Arrhythmia or treated with antiarrhythmic drug
- Surgery type were converted to thoracotomy,
- Massive intraoperative blood loss (> 400ml)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insufflation of carbon dioxide (CO2)After patients were positioned, CO2 was insufflated into right pleural cavity at eight or twenty L/min. during video-assisted thoracoscopic surgery, thoracic pressure, hemodynamic and respiratory parameters were recorded. | Device | Flowrate A, Flowrate B |
Primary outcome
thoracic pressure overshoot
Time frame: one hour during CO2 insufflation
Time and value of thoracic pressure overshoot during CO2 insufflation
Hemodynamic change
Time frame: one hour during CO2 insufflation
Hemodynamic changes during each overshoot including Systolic Blood Pressure, Central Venous Pressure and Heart Rate
Respiratory change
Time frame: one hour during CO2 insufflation
Respiratory changes during each overshoot including Peak Inspiratory Pressure, Pressure flat, Arterial Oxygen Saturation and End-tidal Carbon dioxide
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 24 Feb 2021.
- Background: PubMed 23549763Claus CM, Cury Filho AM, Boscardim PC, Andriguetto PC, Loureiro MP, Bonin EA. Thoracoscopic enucleation of esophageal leiomyoma in prone position and single lumen endotracheal intubation. Surg Endosc. 2013 Sep;27(9):3364-9. doi: 10.1007/s00464-013-2918-3. Epub 2013 Apr 3.
- Background: PubMed 14673684El-Dawlatly AA, Al-Dohayan A, Abdel-Meguid ME, Turkistani A, Alotaiby WM, Abdelaziz EM. Variations in dynamic lung compliance during endoscopic thoracic sympathectomy with CO2 insufflation. Clin Auton Res. 2003 Dec;13 Suppl 1:I94-7. doi: 10.1007/s10286-003-1120-4.
- Background: PubMed 10594427Brock H, Rieger R, Gabriel C, Polz W, Moosbauer W, Necek S. Haemodynamic changes during thoracoscopic surgery the effects of one-lung ventilation compared with carbon dioxide insufflation. Anaesthesia. 2000 Jan;55(1):10-6. doi: 10.1046/j.1365-2044.2000.01123.x.
- Derived from this study: PubMed 35321653Ren Y, Zhu X, Yan H, Chen L, Mao Q. Cardiorespiratory impact of intrathoracic pressure overshoot during artificial carbon dioxide pneumothorax: a randomized controlled study. BMC Anesthesiol. 2022 Mar 23;22(1):76. doi: 10.1186/s12871-022-01621-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Insufflation of carbon dioxide (CO2) in people with Esophageal Neoplasms, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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 3 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
thoracic pressure overshoot (time frame: one hour during CO2 insufflation). The study lists 3 primary outcomes in all. 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 NCT02330536, which also lists 4 linked publications.
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 24 Feb 2021.