HUMAN RESEARCH ETHICS: Assessment
CASE STUDY TWO
Intra-luminal pressure readings/images and video recording whilst achieving a positive "tamponade test" in the management of heavy bleeding in postpartum haemorrhage or following gynaecological surgery.
SUMMARY OF PROJECT
The object of this project is to measure the intra-luminal pressures of a balloon used in the management of postpartum haemorrhage. It is also to challenge the hypothesis that the mechanism by which haemostasis is achieved is by the generation of a raised intrauterine pressure that is "greater than the systemic arterial pressure."
Doctor George Crest BSC (Hons), Ph.D. MBB S, MRCOG, FRANZCOG, consultant and senior lecturer in obstetrics and gynaecology at the State University.
Doctor Crest is the primary doctor involved in patient care in obstetrics in the City Hospital, the primary teaching hospital of the medical school for the State University. Doctor Crest lectures in postpartum haemorrhage and postnatal care and has conducted workshops on the use of the balloon tamponade technology. He is the chief scientific adviser to MedTech Limited, an Australian Corporation that has invented modifications for the balloon technology and holds patent rights to their use.
Doctor Crest has more than 10 years experience in the treatment of postpartum haemorrhage.
The project is being conducted as part of Doctor Crest's research responsibility in his academic role at the State University. The University promotes research by its academic staff and a proportion of salary is dedicated for that purpose. Additional resources are being provided by MedTech Limited primarily in the form of the provision of balloon devices and a new three-way pump that is central to this research project. This "in-kind" support has been provided without cost to the researcher, the hospital or the University.
The project has not been subjected to peer review.
A balloon device is used in the management of postpartum haemorrhage (see references below). This device is inserted into the uterus of a woman who has delivered a baby and who is bleeding profusely. Pharmacological methods have shown varied levels of success in stopping this bleeding although they are used in some centres. If a woman continues to bleed and this bleeding is not stopped she will die.
The balloon device is specifically designed to be used in the management of such cases. Other balloons might also be used in the management of heavy vaginal bleeding following gynaecological surgery.
The balloon is normally supplied with a two-way pump, allowing the injection and removal of fluid to fill and empty the balloon. Although effective in stemming excessive blood flow, is not known what is the optimal range of safe pressures that achieve this result without causing harm. In order to provide this knowledge, this project involves the attachment of a three-way tap that allows simultaneous measurement of the intro-luminal pressure as the balloon is being filled or reduced with fluid. There is no change in the management, sequence of events or timing in deploying this device. The pressure readings are recorded on a laptop computer attached to the three-way tap. The readings are continued whilst the patient is being sutured for a tear in the perineum (lower genital tract) and also whilst on a bed in recovery. Measuring the pressures does not change the management of the patient. The results are analysed after the patient has been transferred to a high dependency unit.
The use of the three-way tap will be a technological innovation. In order to ensure that its use is understood, by obstetricians and midwives, it is proposed to video the use of the three-way tap in this study. With the consent of participants, video footage will be used for instructional purposes. The video will be taken with a Canon digital camera usually by a member of the theatre staff not directly involved with the patient's care.
Georgiou, C Balloon tamponade in the management of postpartum haemorrhage: a review BJOG 2009 116: 748-757
BENEFITS AND RISKS
The benefits of the proposed study are an increased understanding of the optimal pressure ranges for effective and safe use of the balloon mechanism and therefore interventions that can be used to prevent morbidity and mortality from postpartum haemorrhage. Dissemination through publications and conference presentations of an effective method of controlling heavy bleeding following gynaecological surgery will contribute to the reduction of morbidity and mortality from sources related to childbirth.
The clinical treatment using a balloon tamponade technology is well-established and this project does not vary that clinical practice and thus poses no additional risk beyond what would normally be experienced in standard clinical treatment. The use of the three-way tap does not increase any risks.
Pressures within the postpartum uterus have not been measured before. They are recorded to provide information to facilitate current understanding of how to manage stopping uterine bleeding by using the balloon tamponade technology. Currently, efficacy of this technology is believed to be caused by the increase of pressure, but there is no research on the optimal and safe range of such pressures. Accordingly, the recording of these pressures in this study is something that is not a standard part of clinical management.
The video recordings are a crucial component in the dissemination of new methods of technology. The ethical considerations relate to respect for maintaining confidentiality and preventing identification of specific individuals who are the subject of video recording.
In order to address these risks, none of recording includes images of identifiable personal features such as the face of a patient. In addition, the images are reviewed by the principal investigator and the patient before being used in the project so that unsuitable or unacceptable images all recordings can be withdrawn.
Because the project does not involve additional risks to those that are part of standard clinical use of the balloon tamponade technology, no monitoring mechanisms additional to those that are part of normal clinical practice are planned.
Participants will be in-patients in the City Hospital who present emergency situations of post-partum or post-vaginal surgery haemorrage. The nature of these situations and unexpected bleeding will usually preclude approaches for consent to involvement in research before implementing the research processes of measuring pressures and video recording of balloon placement.
Although patients may already be anaesthetised before a decision to use the balloon is made, the use of the balloon is not a research question. It is usually a penultimate step before more serious surgery such as uterine artery vassal ligation or hysterectomy.
Because it is recognised that the majority of gynaecological procedures are conducted with anaesthetised patients, they will be included in the project only where the following conditions are satisfied:
- the principal investigator is available,
- pressure recording devices are available, and
- the clinical situation is considered appropriate, that is where fitting of the three-way tap to measure pressure recording and video recording of balloon placement will not result in a delay in treatment.
In these situations, participants will be provided with an information leaflet and consent form as soon as is convenient and this will be signed at follow-up appointments at 2-4 weeks. (Appendix)
All participants will be debriefed in relation to balloon usage and pressure recordings. In addition, videos will be shown and requests for consent to their use in teaching, presentation and publication will be sought in the follow-up clinic.
Postpartum haemorrhage requiring balloon tamponade is rare: in the last year at the City Hospital there were only five cases. Accordingly, it is presently planned to conduct the research recruitment over a three-year period which will allow the recruitment of a sufficient number of participants to generate statistically valid outcomes to guide practice in the application of optimal ranges of uterine pressure.
The use of the balloon is an emergency measure to control bleeding. Although patients will not be able to refuse the use of the balloon or the recording of pressures, these will not affect their management or care or the use of the balloon as an emergency measure to control bleeding. Afterwards, when patients have returned to the recovery ward, or in the follow-up clinic, the nature of the bleeding requiring intervention will be explained as well as the recording of the intra-luminal pressures.
Participants are requested to allow their case data and pressure recordings to be used for this research project, publication of reports in refereed journals and presentations for teaching and instructional purposes.
All of the potential participants to be approached for involvement in this research study will be in an existing doctor patient relationship with the principal investigator. They will be reminded that they are free to decline to be involved in the study and, if they agree to be involved, to decide whether or not recordings of pressures or video footage obtained during the study may not be used for publication presentations or instructional resources.
The pressure measurements are not part of any patient's specific clinical management. The readings are simultaneously taken during their treatment. There are no adverse effects on their treatment if they withdraw their consent to pressure recordings or to the use of video footage. The video footage and pressure recordings can be destroyed by deleting the data if the patient wishes to do so at the follow-up appointment.
PRIVACY AND CONFIDENTIALITY
Source and description of information about participants
Information about participants will be derived from their involvement in this study with their consent and from video footage taken with their consent.
Use of information about participants
The information about participants will be used to prepare reports of the study and to prepare publications, conference and instructional presentations. In all of these uses, no identifying information about participants will be used.
Storage of information
During the course of the study, all of the data collected about participants will be kept in a password protected laptop computer retained in the principal investigators office, which will be locked.
Ownership of the information
It is understood that the information will be owned by the State University as part of a research project conducted by a staff member using the university's resources.
Reporting of individual results
When participants consent to the collection of pressure readings and video recording, their individual results will be provided to them and that they will review the video footage before it is used.
Disposal of the information
On completion of the study and the preparation of conference presentations and instructional presentations, all data and material derived from the study will be retained for 15 years and will then be destroyed.
APPENDIX: Information Sheet and Consent Form