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Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection

Primary Purpose

Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Permissive hypercapnia
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult >18 yr
  • elective pulmonary resection through thoracotomy.

Exclusion Criteria:

  • Patients with pulmonary hypertension (systolic >50mmHg),
  • intracranial hypertension or previous intracranial haemorrhage,
  • pre-existing hypercapnia,
  • co-existing metabolic acidosis,
  • ischaemic heart disease,
  • predicted postoperative FEV1<800 ml or <40% of the expected in pneumonectomy
  • patient in which transesophageal echocardiography was contraindicated or necessary measurements were difficult to assess.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    permissive hypercapnia

    Arm Description

    during one lung ventilation, right ventricular function was assessed by TEE and the effect of rising PCO2 appreciated

    Outcomes

    Primary Outcome Measures

    Right ventricular systolic and diastolic functions measured by Tei index
    Tei index and Tricuspid Annular Plane Systolic Excursion (TAPSE) were used to assess both RV systolic and diastolic functions

    Secondary Outcome Measures

    Full Information

    First Posted
    June 20, 2015
    Last Updated
    August 6, 2015
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02519517
    Brief Title
    Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
    Official Title
    Acute Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy. Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV) and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35 mm Hg. Data were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures analysis of variance (ANOVA), with post hoc Dunnet´s test were used for analysis. A P value < 0.05 is considered statistically significant.
    Detailed Description
    Investigators studied 15 patients scheduled for elective pulmonary resection through thoracotomy. Patients had a standardized management for thoracotomies. Initial VT 10ml/ kg was reduced to 8ml/kg after OLV and the rate adjusted to maintain PaCO2 30-35 mm Hg. Haemodynamic, respiratory variables and echocardiographic data (Tei index and TAPSE) were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures ANOVA, with post hoc Dunnet´s test were used for analysis. A P value < 0.05 is considered statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    permissive hypercapnia
    Arm Type
    Experimental
    Arm Description
    during one lung ventilation, right ventricular function was assessed by TEE and the effect of rising PCO2 appreciated
    Intervention Type
    Procedure
    Intervention Name(s)
    Permissive hypercapnia
    Intervention Description
    During one lung ventilation, right ventricular function was assessed by transesophageal echocardiography (TEE) and the effect of increased carbon dioxide pressure was evaluated
    Primary Outcome Measure Information:
    Title
    Right ventricular systolic and diastolic functions measured by Tei index
    Description
    Tei index and Tricuspid Annular Plane Systolic Excursion (TAPSE) were used to assess both RV systolic and diastolic functions
    Time Frame
    Intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adult >18 yr elective pulmonary resection through thoracotomy. Exclusion Criteria: Patients with pulmonary hypertension (systolic >50mmHg), intracranial hypertension or previous intracranial haemorrhage, pre-existing hypercapnia, co-existing metabolic acidosis, ischaemic heart disease, predicted postoperative FEV1<800 ml or <40% of the expected in pneumonectomy patient in which transesophageal echocardiography was contraindicated or necessary measurements were difficult to assess.

    12. IPD Sharing Statement

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