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Trial registered on ANZCTR


Registration number
ACTRN12609000979257
Ethics application status
Approved
Date submitted
28/12/2008
Date registered
13/11/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Application of Nonivasive ventilation in the Post-operative patients undergoing Roux-en-Y Gastric Bypass
Scientific title
Application of Noninvasive Ventilation Against Oxygen Therapy on the Post-Operative Patients Undergoing Roux-en-Y Gastric Bypass to Prevent Pulmonary Complications After Surgery
Secondary ID [1] 1128 0
Incidence of dehiscence of gastro-jejunal anastomosis in the postoperative gastric bypass in-en-Y gastric bypass.
Universal Trial Number (UTN)
Trial acronym
Noninvasive ventilation in the postoperative bariatric surgery
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of noninvasive ventilation with bi-level positive airway pressure (BiPAP) on the lung function in morbid obese patients that underwent a Roux-en-Y gastric bypass procedure (RYGB). 4157 0
Incidence of post-operatory lung complications 4158 0
Development of anastomotic leakage after surgery. 4159 0
Condition category
Condition code
Respiratory 4367 4367 0 0
Normal development and function of the respiratory system
Physical Medicine / Rehabilitation 4368 4368 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ventilation with intermittent positive pressure noninvasive (NIPPV) was conducted by non-invasive ventilator synchrony spontaneous-timed (ST) Bilevel pressure (BiPAP), marca registrada, (Respironics, Murrysville, Pennsylvania, USA), in spontaneous-timed mode (ST), with positive inspiratory pressure (IPAP) adjusted 12 cm water, expiratory positive pressure (EPAP ) on 8 cm water, inspiratory time of 0.8 seconds, the respiratory rate of 08 breaths per minute, the rise time of 1 second, the slope of 0.5 cm water and oxygen flow to 4 L / min. Used as patient-ventilator interface nasal mask with headgear.
NIPPV was performed in the first four hours of post-operative period immediately after extubation in recovery room
Intervention code [1] 3875 0
Prevention
Comparator / control treatment
The control group received support oxygen at 4 L / minute via nasal cannula type glasses, after extubation, according to the protocol of the service.
support oxygen was performed in the first four hours of post-operative period immediately after extubation in recovery room
Control group
Active

Outcomes
Primary outcome [1] 5242 0
Statistical difference in relation to loss of vital capacity (CV) in the first postoperative day, compared to preoperative values between the groups.
The CV was measured using the analog Ohmeda spirometer, model RM 121, Japan, with the patient seated with supported
feet, nostrils occluded with nose clip, starting from total lung capacity (CPT) to residual volume (VR ) and performed three measures, with 1 minute between them and adopting as a result most of them.
Timepoint [1] 5242 0
It was considered preoperatively the day before surgery, and postoperative day 1 (twenty four hour after surgery). All measurements were performed by the same examiner.
Primary outcome [2] 253224 0
Statistical difference in relation to loss of Maximal inspiratory mouth pressures (PIMAX) in the first postoperative day, compared to preoperative values between the groups.
The PIMAX was obtained with the use of a manometer Support brand, class B, Brazilian industry, with scale ranging from 0 to 150 cm water, connected to the patient through the mouthpiece of hard plastic. We measured the Pimax from the VR, always with the patient seated and with the nostrils occluded with a nose clip. A small hole was made in the nozzle to prevent glottic closure during the maneuver, the cheeks were contained by a hand of the patient. Every effort should be sustained for at least 1 second. The maneuver was repeated three to five times, until three values were obtained with a variation less than 10% between them, with 1 minute between efforts. Adopted as a result of greater extent, except that arising from the last manobra. The reference equations for maximal respiratory pressures proposed by Pereirawere used.
Timepoint [2] 253224 0
It was considered preoperatively the day before surgery, and postoperative day 1 (twenty four hour after surgery). All measurements were performed by the same examiner.
Primary outcome [3] 253225 0
Statistical difference in relation to loss of Maximal expiratory mouth pressures (PEMAX) in the first postoperative day, compared to preoperative values between the groups.
The Pemax was obtained with the use of a manometer Support brand, class B, Brazilian industry, with scale ranging from 0 to 150 cm water, connected to the patient through the mouthpiece of hard plastic.We measured the Pemax from the CPT, always with the patient seated and with the nostrils occluded with a nose clip. A small hole was made in the nozzle to prevent glottic closure during the maneuver, the cheeks were contained by a hand of the patient. Every effort should be sustained for at least 1 second. The maneuver was repeated three to five times, until three values were obtained with a variation less than 10% between them, with 1 minute between efforts. Adopted as a result of greater extent, except that arising from the last manobra. The reference equations for maximal respiratory pressures proposed by Pereirawere used.
Timepoint [3] 253225 0
It was considered preoperatively the day before surgery, and postoperative day 1 (twenty four hour after surgery). All measurements were performed by the same examiner.
Primary outcome [4] 253226 0
Statistical difference in relation to loss partial pressure of oxygen in arterial blood (PaO2) and oxygen saturation in arterial blood (SaO2) in the first postoperative day, compared to preoperative values between the groups.
The arterial blood was collected in the radial artery with the patient breathing room air, supine, using a 1 ml syringe, lubricate it with heparin, needle size 4.5 x 13 mm, preoperative and postoperative day 1. The processing of the examination was conducted in the gas tank brand Radiometer ABL 700 Series.
Timepoint [4] 253226 0
It was considered preoperatively the day before surgery, and postoperative day 1 (twenty four hour after surgery). All measurements were performed by the same examiner
Secondary outcome [1] 8840 0
Comparison of the incidence of abdominal distention and / or leakage of anastomosis between the groups.
The integrity of the gastro-jejunal anastomosis was evaluated by the surgeon in charge, before the start of feeding in the second PO, test using methylene blue procedure, the dilution of 5 ml of methylene blue in 100 ml saline, administered orally, 20 in 20 ml every twenty minutes until the end of the solution. The result was evaluated by the drain of the abdominal cavity, positioned near the gastro-anastomosis jejunal.
Timepoint [1] 8840 0
Was considered second post-operative, the period of forty-eight hours after surgery.
Secondary outcome [2] 262147 0
Comparison of the incidence of atelectasia and / or pneumoperitoneum between the groups.
Chest radiography was performed on the third postoperative day.
Timepoint [2] 262147 0
Was considered third post-operative, the period of seventy-two hours after surgery.
Secondary outcome [3] 262148 0
All patients had normal chest X-ray preoperatively, with low risk for developing pulmonary complications in the postoperative period according to the Torrington & Henderson.
Timepoint [3] 262148 0
The moment of the evaluation were preoperative . It was considered preoperatively the day before surgery

Eligibility
Key inclusion criteria
Patients with the body mass index of at least 40 kg/ m2, that underwent the RYGB
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with severe or chronic lung diseases and those whom received invasive mechanical ventilation in the post-operatory

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients were divided randomly by drawing lots in sealed envelopes into two groups: one received NIV in the first four hours of the postoperative period (IOP) immediately after extubation in the recovery room (group study) and the second support received oxygen at 4 L / minute via nasal cannula type glasses, after extubation, according to the protocol of the service (control group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients were divided randomly by drawing lots in sealed envelopes into two groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1500 0
Brazil
State/province [1] 1500 0
Maranhao

Funding & Sponsors
Funding source category [1] 244005 0
Hospital
Name [1] 244005 0
Hospital Universitario Presidente Dutra
Country [1] 244005 0
Brazil
Primary sponsor type
Individual
Name
Researcher
Address
Rua Barao do Itapary, Numero: 227
Bairro: Centro
Sao Luis-Maranhao
CEP:65070-905
Country
Brazil
Secondary sponsor category [1] 251356 0
None
Name [1] 251356 0
Address [1] 251356 0
Country [1] 251356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6382 0
The Research Ethics Committee of the university hospital of the unversity federal of Maranhao unversidade of Maranhao
Ethics committee address [1] 6382 0
Ethics committee country [1] 6382 0
Brazil
Date submitted for ethics approval [1] 6382 0
01/10/2005
Approval date [1] 6382 0
11/04/2006
Ethics approval number [1] 6382 0
1/06/0104

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35061 0
Address 35061 0
Country 35061 0
Phone 35061 0
Fax 35061 0
Email 35061 0
Contact person for public queries
Name 12408 0
Kivania Carla Pessoa
Address 12408 0
Avenida dos Holandeses, Numero:02 Quadra 32
Bairro: Calhau
Maranhao/Sao Luis
CEP:65071-380
Country 12408 0
Brazil
Phone 12408 0
55 (98) 3235-2345
Fax 12408 0
Email 12408 0
[email protected]
Contact person for scientific queries
Name 3336 0
Kivania Carla Pessoa
Address 3336 0
Avenida dos Holandeses, Numero:02 Quadra 32
Bairro: Calhau
Maranhao/Sao Luis
CEP:65071-380
Country 3336 0
Brazil
Phone 3336 0
55 (98) 3235-2345
Fax 3336 0
Email 3336 0
[email protected]

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