NCT02330536

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

5.6 years

First QC Date

December 24, 2014

Last Update Submit

February 22, 2021

Conditions

Esophageal Neoplasms

Keywords

Circulatory and Respiratory Physiological PhenomenaThoracoscopy

Outcome Measures

Primary Outcomes (3)

  • thoracic pressure overshoot

    Time and value of thoracic pressure overshoot during CO2 insufflation

    one hour during CO2 insufflation

  • Hemodynamic change

    Hemodynamic changes during each overshoot including Systolic Blood Pressure, Central Venous Pressure and Heart Rate

    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

    one hour during CO2 insufflation

Study Arms (2)

Flowrate A

EXPERIMENTAL

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

Device: Insufflation of carbon dioxide (CO2)

Flowrate B

EXPERIMENTAL

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

Device: Insufflation of carbon dioxide (CO2)

Interventions

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.

Flowrate AFlowrate B

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23549763BACKGROUND

  • 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.

    PMID: 14673684BACKGROUND

  • 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.

    PMID: 10594427BACKGROUND

  • 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.

    PMID: 35321653DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 24, 2014

First Posted

January 5, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02