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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519517
• Other study ID #: acute permissive hypercapnia
• Status: Completed
• Phase: N/A
• First received: June 20, 2015
• Last updated: August 6, 2015
• Start date: November 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2015
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Anesthesia
• Hypercapnia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperative	No