Postoperative Pulmonary Complications in Major Abdominal Surgery

Postoperative Complications Clinical Trial

— PPC  

Official title:

Postoperative Pulmonary Complications in Major Abdominal Surgery: Prospective Observational Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914328
• Other study ID #: PPC 01
• Status: Completed
• Start date: June 2013
• Est. completion date: January 2020

Study information

• Verified date: January 2020
• Source: Azienda Ospedaliera S. Maria della Misericordia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the incidence of pulmonary complications in patients undergone major abdominal elective surgery performed under general anesthesia.

Description:

PRIMARY AIM:

The primary aim of the study is to evaluate the incidence and characteristics of postoperative pulmonary complications (PPC) in patients undergoing major abdominal surgery.

SECONDARY AIM:

The secondary aim of the study is to define the incidence of postoperative infections, cardiovascular complications, postoperative residual curarization (PORC), duration of ventilatory support, need of re-intubation, need of ICU admission and ICU length of stay, total length of hospitalization, mortality during hospitalization and postoperative outcome (assessed at 30, 60 days and 1 year after hospital discharge).

MATERIALS AND METHODS

SAMPLE SIZE:

1500 patients

Definitions of Pulmonary Complications Complications are defined as respiratory infection, postoperative respiratory failure, pleural effusion, pneumothorax, atelectasis, aspiration pneumonia, bronchospasm, need of oxygen supplementation or noninvasive ventilatory support or urgent re-intubation.

Recruitment and Monitoring Procedures

All patients scheduled for elective major abdominal surgery, urologic surgery or major gynecological surgery under general anaesthesia will be enrolled in this study.

Patients will be monitored in the postoperative period and will receive, standard postoperative care, as directed by the clinical teams and if indicated, antibiotics, diuretics, oxygen therapy and every therapy according to the underlying disease. Medical and nursing staff will monitor peripheral oxygen saturation in the origin ward.

Data Collection:

A form divided in three sections (pre/intra/postoperative period) will be used for data collection. Data will be collected on paper support and then entered in an electronic CRF.

Data will be anonymous. Every patient will be identified by a six number code: first three (from left to right) identify the participating center, the others identify the sequential number of enrollment.

The data insertion will be done by the investigators of every participating center, using a personal username and password.

Data will be sent to the coordinator center where the data cleaning will be completed and statistical analysis will be performed with this timing:

• after the 15 days enrolment period;

• after 4 months from the beginning of the study (30 days postoperative follow up);

• after 6 months from the beginning of the study (60 days postoperative follow up);

• after 16 months from the beginning of the study (1 year postoperative follow up) Every center will store its own paper Case Report Form(CRF).

Sample size Calculation:

1500 patients undergoing elective major abdominal surgery, urologic surgery or major gynecological surgery under general anaesthesia will be enrolled.

On the basis of published studies in the literature (Squadrone et al. (16%), Lawrence et al.(4.5%), Hall et al.(15%), Mitchell et al.(11%) e Canet et al. (7.2%), the investigators supposed that the primary outcome (PaO2/FiO2 <300) will be around 7%. Using a 0.05 two tails alfa, we can obtain a precise two tails 95% confidence intervals (5.8% -8.4% according to the Wald adjusted method), obtaining a sample size of 1422 patients (software STATA 9.0).

Statistical Analysis:

Statistical analysis will be carried out on all collected cases. We will evaluate all the variables considered in the CRF and, for every variable, we will carry out descriptive analysis: mean, median, standard deviation, range, minimum and maximum value for continuous variables; absolute and relative frequencies for categorical variables.

It will also be assessed the possible interdependence between two or more variables and any associations between disease characteristics and therapeutic interventions administered and described in the CRF, using parametric statistical tests, even at multivariate level. We will perform the basic descriptive statistics of the variables considered.

Statistical comparison of continuous variables will be conducted with "t Student test", while "chi square test" will be used for categorical variables. The odds ratio will be calculated and finally logistic regression will be conducted for the analysis of predictivity.

The study also recognizes the possibility to perform additional analysis not planned in the protocol but suggested by the results of planned analyzes described above.

Data will be stored in electronic format and analyzed using the softwares Epi Info 2002 (CDC), SPSS 11.0 (SPSS), and STATA 9.0 (STATA) when appropriate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: January 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years

• Ability to provide informed consent

• Elective surgery

• Laparotomic or laparoscopic major abdominal surgery

• Major urological surgery (performed under general anesthesia)

• Major gynecological surgery (performed under general anesthesia)

Exclusion Criteria:

• Patients undergoing urgent or emergent surgery

• Patients undergoing: vascular, thoracic ,cardiac surgery, neurosurgery, obstetrics procedures and transplantation surgery

• Patients with chronic neuro-muscular junction disorders

• Immunocompromised or immunodepressed patients

• Patients with chronic or acute respiratory disease (acute respiratory infection, bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome)

• Patients with preoperative mechanical ventilation

• Patients who needed mechanical ventilation in the last 30 days

• Patients with preoperative SpO2 <90%, PaO2 <60 mmHg (FiO2 0.21), or a PaO2/FiO2 ratio <300, or PaCO2 >45 mmHg.

Related Conditions & MeSH terms

• Postoperative Complications
• Postoperative Respiratory Complications
• Surgical Site Infection
• Surgical Wound Infection

Locations

Country	Name	City	State
Italy	CRO	Aviano	PN
Italy	AO Benevento	Benevento	BN
Italy	Ospedale Bologna	Bologna	BO
Italy	Sant'Orsola Bologna	Bologna	BO
Italy	Ospedali Civili	Brescia	BS
Italy	Sant'Anna di San Fermo della Battaglia	Como	CO
Italy	Ospedale Cremona	Cremona	CR
Italy	AOS S.Croce e Carle	Cuneo	CN
Italy	Università degli studi di Ferrara	Ferrara	FE
Italy	Ospedale S. Maria Nuova	Firenze	FI
Italy	AOU Foggia	Foggia	FG
Italy	Ospedala Macerata	Macerata	MC
Italy	IRCCS Istituto Nazionale Tumori	Milano	MI
Italy	Ospedale San Raffaele	Milano	MI
Italy	Ospedale Montebelluna	Montebelluna	TV
Italy	Ospedale Monaldi	Napoli
Italy	AO Grassi	Ostia	RM
Italy	Ospedale Cisanello Pisa	Pisa	PI
Italy	A.Gemelli Università Cattolica	Roma	RM
Italy	Campus Biomedico	Roma	RM
Italy	Umberto I, Università Sapienza	Roma	RM
Italy	Ospedale Savona	Savona	SV
Italy	IRCCS	Sesto San Giovanni	MI
Italy	IRCC Candiolo	Torino	TO
Italy	Ospedale di Trento	Trento	TN
Italy	USSL 9 Veneto	Treviso	TV
Italy	AOU	Udine	UD
Italy	Ospedale Civile Vicenza	Vicenza	VI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera S. Maria della Misericordia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim of the study is to evaluate the incidence of postoperative pulmonary complications (PPC) in patients undergoing major abdominal surgery.	Complications are: respiratory infection, postoperative respiratory failure, pleural effusion, pneumothorax, atelectasis, aspiration pneumonia, bronchospasm, need of oxygen supplementation or noninvasive ventilatory support or unplanned urgent re-intubation.; Respiratory infection is defined as appearance of a new infiltrate on chest radiograph combined with at least two of the following criteria: body temperature greater than 38°C or less than 35.5°C, white blood cell count greater than 12000/mm3 or smaller than 4000/mm3, presence of purulent sputum.Respiratory failure is defined as a postoperative oxygen saturation by pulse oximetry (SpO2) less than 90%, or a PaO2/FiO2 ratio less than 300, a partial arterial pressure of carbon dioxide (PaCO2) greater than 45 mmHg, onset of dyspnea with respiratory distress and/or use of accessory muscles of respiration. The pleural effusion is identified as an opacity at the chest radiograph that was not present in previous radiographs or ultrasound	5 Weeks after surgery
Secondary	The secondary aim of the study is to define the length of hospitalization in patients undergoing major abdominal surgery.	Length of hospitalization is defined as the time spent from the day of surgery to the day of hospital discharge	5 Weeks after surgery
Secondary	The secondary aim of the study is to define the incidence of mortality in patients undergoing major abdominal surgery		5 Weeks after surgery, 60 days and 1 year after discharge
Secondary	Incidence of postoperative surgical infections	Surgical infections are defined as an infection of the surgical site or directly connected to the surgical procedure	5 Weeks after surgery, 30-60 days after discharge
Secondary	Incidence of cardiovascular complications	Cardiovascular complications are defined as arrhythmias, acute coronary syndrome, myocardial failure, angina pectoris.	5 Weeks after surgery, 30, 60 days, 1 year after discharge
Secondary	Incidence of postoperative residual curarization	Symptoms related to postoperative residual curarization are: evident muscle fatigue or 'fade' due to continuing occupation of presynaptic receptors by molecules of curare; attenuation of the hypoxic reflex due to the inhibition of functional nicotinic cholinergic receptors of the carotid glomus; pharyngolaryngeal dysfunction with loss of airway patency and the risk of "aspiration".; Reduction of the cough reflex, and reduced expansion of the rib cage, with superficial ventilation and often inadequate and decreased clearance of tracheobronchial secretions	5 Weeks after surgery
Secondary	Duration of ventilatory support		5 Weeks after surgery
Secondary	Incidence of Re-Intubation		5 Weeks after surgery
Secondary	Incidence of ICU admission		5 Weeks after surgery
Secondary	Incidence of ICU length of stay		5 Weeks after surgery

External Links

•   electronic Case Report Form (eCRF) site