- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519517
Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
August 6, 2015 updated by: Hisham Hosny, Cairo University
Acute Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: permissive hypercapnia
during one lung ventilation, right ventricular function was assessed by TEE and the effect of rising PCO2 appreciated
|
During one lung ventilation, right ventricular function was assessed by transesophageal echocardiography (TEE) and the effect of increased carbon dioxide pressure was evaluated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Right ventricular systolic and diastolic functions measured by Tei index
Time Frame: Intraoperative
|
Tei index and Tricuspid Annular Plane Systolic Excursion (TAPSE) were used to assess both RV systolic and diastolic functions
|
Intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 20, 2015
First Submitted That Met QC Criteria
August 6, 2015
First Posted (Estimate)
August 11, 2015
Study Record Updates
Last Update Posted (Estimate)
August 11, 2015
Last Update Submitted That Met QC Criteria
August 6, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- acute permissive hypercapnia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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