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
About this trial
This is an interventional screening trial for Anesthesia
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.
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
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
Learn more about this trial
Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
We'll reach out to this number within 24 hrs