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

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ClinicalTrials.gov Identifier: NCT02519517
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Hisham Hosny, Cairo University

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.

Condition or disease Intervention/treatment Phase
Anesthesia Procedure: Permissive hypercapnia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Acute Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
Study Start Date : November 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: permissive hypercapnia
during one lung ventilation, right ventricular function was assessed by TEE and the effect of rising PCO2 appreciated
Procedure: Permissive hypercapnia
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 Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Hisham Hosny, Assistant (associate) professor, Cairo University
ClinicalTrials.gov Identifier: NCT02519517    
Other Study ID Numbers: acute permissive hypercapnia
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Hypercapnia
Signs and Symptoms, Respiratory