Capnography During Nurse Administered Propofol Sedation

NCT01220765 | Completed

• 1 other identifier: NL 29266.041.09
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The current standard of respiratory monitoring for patients during deep sedation is continuous pulse oximetry with visual assessment of the patient. Clinical research has demonstrated that depressed respiratory activity is a principal risk factor for hypoxemia during sedation. Capnography may provide early detection of alveolar hypoventilation before hypoxemia has occurred in nonintubated patients and thereby improve patient safety during sedation. 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 capnography in early detection of alveolar hypoventilation during deep sedation in comparison to standard monitoring with pulse oximetry in abortion procedures. Study design: This protocol describes a prospective, open, randomized controlled trial with two study arms. All patients receive standard care of monitoring performed by the medical staff. The study investigates whether capnography prevents patients from having respiratory events during deep sedation in abortion procedures by early detection and therapy. Patients randomized to the standard care group receive standard of respiratory monitoring using pulse oximetry. In the capnography arm, respiratory monitoring is performed with pulse oximetry and capnography. Study population: The study population comprises female patients (≥ 18 years) undergoing abortion procedures during first or second trimester pregnancies. Abortion procedures are performed until 22 weeks of gestational age. Capnography: In addition application of capnography during deep sedation with propofol is performed. Before the trial starts, all nurses qualified in patient sedation management and abortion doctors will be trained in assessment of capnography. In the capnography arm, patients' breathing is additionally monitored with capnography. If alveolar hypoventilation is detected medical staff will 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. Main study parameters/endpoints: The primary outcome is the occurrence of oxygen saturations to ≤90% in the population, as measured by continuous pulse oximetry. Secondary study outcomes include occurrence of oxygen saturations \< 80%, dose of administered propofol, arousal or movement of the patient during the procedure, airway interventions, early termination of the procedure due to respiratory problems, episodes of bradycardia, and administration of atropine. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 capnography group could get benefit from the addition of capnography to the monitoring by early detection of alveolar hypoventilation. 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.

Conditions

Alveolar Hypoventilation Resulting in Hypoxemia

Keywords

hypoxemia; capnography; sedation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients having saturations (SpO2 below 90%) in the two arms

  Occurrence of oxygen saturations below 90% measured by continuous pulse oximetry in the two study arms; capnography vs. standard care

  Desaturations during the sedation procedure, within 1 hour after administering the first propofol dose

Secondary Outcomes (2)

• proportion of patients necessitating airway interventions

  Airway interventions during the sedation procedure within 1 hour after the first propofol dose

• Proportion of patients having deep desaturations (SpO2 below 80%) in the two study arms

  Desaturations during the sedation procedure, within 1 hour after the first propofol dose

Study Arms (2)

Standard care

NO INTERVENTION

Patients randomized to the standard care group receive standard of care using pulse oximetry

Capnography

EXPERIMENTAL

In the intervention group capnography is measured using a cannula under the nose connected to the capnograph. The capnographic device displays respiratory rate, end-tidal carbon dioxide (ETCO2) levels, and continuous waveforms.

Device: Capnography

Interventions

Capnography DEVICE

In the capnography arm, respiratory monitoring is performed with pulse oximetry and capnography. If the capnogram indicates sub-optimal ventilation and/or apnea, denoted as a flat line on the capnometer for ≥ 15 seconds, a respiratory rate ≤ 6, or a end-tidal CO2 \> 50 mmHg, medical staff will intervene by arousing the patient, performing chinlift or jawthrust, abandon from giving additional propofol, or provision of oxygen. The nurse qualified in sedation management will assess capnography him/ herself.

Also known as: Capnograph, Capnostream TM 20, Oridion Medical 1987 ltd.

Capnography

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• UMC Utrecht: lead
• CASA, Leiden: collaborator

Study Sites (1)

CASA, Centre for Contraception, Sexuality and Abortion clinic,

Leiden, 2313 DH, Netherlands

Location

Related Publications (7)

• Vargo JJ, Zuccaro G Jr, Dumot JA, Shermock KM, Morrow JB, Conwell DL, Trolli PA, Maurer WG. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002 Jul;123(1):8-16. doi: 10.1053/gast.2002.34232.

  PMID: 12105827 BACKGROUND

• Griffin SM, Chung SC, Leung JW, Li AK. Effect of intranasal oxygen on hypoxia and tachycardia during endoscopic cholangiopancreatography. BMJ. 1990 Jan 13;300(6717):83-4. doi: 10.1136/bmj.300.6717.83. No abstract available.

  PMID: 2105779 BACKGROUND

• Colman Y, Krauss B. Microstream capnograpy technology: a new approach to an old problem. J Clin Monit Comput. 1999 Aug;15(6):403-9. doi: 10.1023/a:1009981115299.

  PMID: 12578035 BACKGROUND

• Lightdale JR, Goldmann DA, Feldman HA, Newburg AR, DiNardo JA, Fox VL. Microstream capnography improves patient monitoring during moderate sedation: a randomized, controlled trial. Pediatrics. 2006 Jun;117(6):e1170-8. doi: 10.1542/peds.2005-1709. Epub 2006 May 15.

  PMID: 16702250 BACKGROUND

• Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.

  PMID: 19422079 BACKGROUND

• Grobbee DE, Hoes AW. Randomized trials. In: Grobbee DE, Hoes AW, editors. Clinical Epidemiology. Sudbury: Jones and Bartlett; 2008. p. 270-287.

  BACKGROUND

• Clarke JP. Sedation for endoscopy: the safe use of propofol by general practitioners. Med J Aust. 2002 Aug 5;177(3):163-4; author reply 165. doi: 10.5694/j.1326-5377.2002.tb04712.x. No abstract available.

  PMID: 12149092 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Interventions

Capnography

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 14, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 10, 2011

Record last verified: 2010-04

Locations

NL (1)