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OpenTrials
Completed

NCT Number: NCT02519517

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Permissive hypercapnia

Procedure

During one lung ventilation, right ventricular function was assessed by transesophageal echocardiography (TEE) and the effect of increased carbon dioxide pressure was evaluated

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2015
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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