Cardiopulmonary Effects of Intrathoracic Pressure Overshoot During Carbon Dioxide Insufflation in Thoracoscopic Surgery

NCT ID: NCT02330536

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Flowrate A

insufflation of carbon dioxide at 8L/min, 8mmHg

Group Type EXPERIMENTAL

Insufflation of carbon dioxide (CO2)

Intervention Type 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.

Flowrate B

insufflation of carbon dioxide at 20 L/min, 8mmHg

Group Type EXPERIMENTAL

Insufflation of carbon dioxide (CO2)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* American Society of Anesthesiologists (ASA) Physical Status Ⅰ,Ⅱ
* Patients with esophageal carcinoma
* Elective video-assisted thoracic surgery

Exclusion Criteria

* 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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Qingxiang Mao

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23549763 (View on PubMed)

El-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.

Reference Type BACKGROUND
PMID: 14673684 (View on PubMed)

Brock 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.

Reference Type BACKGROUND
PMID: 10594427 (View on PubMed)

Ren 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.

Reference Type DERIVED
PMID: 35321653 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QMao

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.