At the Centre for Contraception, Sexuality and Abortion Leiden, abortion procedures are performed under deep sedation using Propofol. Patient*s monitoring is performed by nurses qualified in patient sedation management, using pulse oximetry and…
ID
Source
Brief title
Condition
- Other condition
- Abortions and stillbirth
Synonym
Health condition
iatrogeen veroorzaakte hypoventilatie door sedatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome for both groups is the number of patients with oxygen
saturations to <=90% (minor hypoxemia), as measured by continuous pulse
oximetry.
Secondary outcome
Secondary study outcomes are the number of patients with saturations to <=80%
(major hypoxemia), dose of administered propofol, problems during the abortion
procedure, airway interventions, early termination of the procedure due to
respiratory problems, episodes of bradycardia, and administration of atropine.
Background summary
The current standard of care for patients during deep sedation is continuous
pulse oximetry with visual assessment of the patient. Clinical research has
demonstrated that hypoxemia secondary to depressed respiratory activity is a
principal risk factor during sedation. Capnography may provide early detection
of alveolar hypoventilation before hypoxemia has occurred in nonintubated
patients and thereby improve patient safety during sedation.
Study objective
At the Centre for Contraception, Sexuality and Abortion Leiden, abortion
procedures are performed under deep sedation using Propofol. Patient*s
monitoring is performed by nurses qualified in patient sedation management,
using pulse oximetry and their clinical judgement. The aim of this study is to
examine the effectiveness of microstream capnography in early detection of
alveolar hypoventilation during deep sedation in compare to standard monitoring
with pulse oximetry in abortion procedures.
Study design
The protocol contains a prospective, open, randomized controlled trial with two
study arms. All patients receive standard care of monitoring performed by the
medical staff. The randomized trial examines whether capnography prevents
patients from having respiratory events during deep sedation in abortion
procedures. Patients randomized in the control group receive standard of care
using pulse oximetry. In the intervention arm, respiratory monitoring is
performed with pulse oximetry and capnography. Before the trial starts, all
nurses qualified in patient sedation management and abortion doctors will be
trained in assessment of capnography. The nurses qualified in patient sedation
management then interpret the capnographic signal. If signals are indicating
alveolar hypoventilation, the medical staff can anticipate.
Intervention
The intervention comprises application of capnography during deep sedation with
propofol. In the intervention arm, patients* breathing is additionally
monitored with capnography. If alveolar hypoventilation is detected medical
staff can intervene by arousing the patient, performing chin lift,
repositioning the head, provision of oxygen, or abandon from giving additional
propofol. These interventions represent the standard of care currently used by
the clinical staff to respond to hypoventilation and hypoxemia.
Study burden and risks
The risks related to the conduct of this study are negligible and the burden
minimal. Patients in both groups receive the current standard of care. Patients
randomized in the intervention group would get benefit form the addition of
capnography to the monitoring by early detection of alveolar hypoventilation.
Patients are charged with a single questionnaire before the survey. Capnography
is a noninvasive measurement by means of a cannula under the nose, which before
the sedation may tickle, but during sedation no inconvenience is expected.
Lammerschansweg 15
2313 DH Leiden
Nederland
Lammerschansweg 15
2313 DH Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Age 18 years or older
Abortion procedures performed until 22 weeks of gestational age
American Society of Anaesthesiologists (ASA) classes I to II (normal healthy patients or patients with a mild systemic disease)
Ability to give written informed consent.
Exclusion criteria
Inability to provide written informed consent
History of allergic reactions to propofol, soybeans or egg proteins
American Society of Anaesthesiologists (ASA) classes III to V (patients with a severe systemic disease, with or without constant threat to life, or moribund patients)
Sleep apnea syndrome
Patients with known seizure disorders
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29266.041.09 |